823 Validation Engineer jobs in Singapore

Responsibilities:

• Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.
• Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Assist in review and preparation of process/production equipment validation and computer systems validation
• Review and approval of all Data Integrity – related activities and training including periodic reviews and status report to management
• Improve and add to existic Data Integrity knowledge base, identify training requirements and serve as SME for the same
• Serve as Validation Point of Contact and thus review all validation/qualification documents related to facilities, utilities and equipment.
• Train all site personnel in validation area, provide training and prepare for both internal and external audit and investigations that follow
• Hands on Computerized Systems Validation GAMP5/21CFR

Requirements:

• Minimum 5 years in Quality Management Systems and Proficient in leading Validation, Computerized Systems/SDLC, Change Management, Manufacturing Quality, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management
• Minimum bachelor's or master's degree
• GMP & GDP Certificate is plus
• Well versed with Regulatory Guidelines – USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP <1050>, GAMP5, ISO, WHO etc

• Manages Customer Validations ensuring that all validation activities are carried out in compliance with Customer requirements, STERIS policies & procedures, ISO 11135, and ISO 13485, relevant international standards, directives, and regulations.
• Establishes strong Customer relations and provides exceptional Customer service to ensure Customer qualification requirements are met or exceeded throughout all stages of the validation.
• Proactively supports their direct Supervisor to successfully achieve departmental and site objectives and undertake assigned projects.
• Adopts positive cross functional relations. Liaises with quality, operations planning, laboratory and Customer Service to coordinate and progress Customer validations and projects.
• Collaborates with EO TechTeam to support the establishment of best practice approach through knowledge sharing and providing recommendation for EO TechTeam harmonization.

• Responsible to provides Customer Support & Technical Expertise to Manages Customer new product performance qualification (MPQ & PPQ), ensuring that all new qualification activities are carried out in compliance with Customer requirements, including developing new protocols and report in accordance with STERIS global standards policies & procedures, ISO 11135, and ISO 13485, relevant international standards, directives, and regulations. Establishes strong Customer relations and provides exceptional Customer service to ensure Customer new product qualification requirements are met or exceeded throughout all stages of the validation.

• Supported the department lead/teammate in implementing customer product re-qualification (RPQ), EO chamber operational re-qualification (ORQ) & new validation program (SEO), including customer meetings, technical discussions, protocol development, and report preparation in accordance with STERIS validation global standards policies & procedures.

• Data Logger Management – Responsible for overseeing the system to ensure all data loggers used in validation are functioning properly, including program setup, data download, and performing pre- and post-calibration for each customer or chamber qualification, ensuring timely calibration compliance.

• Assist the department lead/Manager in overseeing and controlling PLC recipe programs for both validation and routine cycles.

Bachelor's Degree in Engineering General or Science

Diploma/Degree in life-science or Engineering with a minimum of 1 years industrial experience with knowledge of ISO13485, process validation and Microbiological/chemical testing. Knowledge of EO sterilisation process and ISO 11135 desirable.

In lieu of meeting the minimum educational requirement applicants with a minimum of 3 years industrial experience preferably in EO sterilisation, demonstrating strong technical skills with comprehensive working knowledge of quality standards ISO11135 and ISO13485 process validation and Microbiological/chemical testing associated with the EO sterilisation process will be considered.

Work Requirements

1. Strong technical writing, scientific writing and problem-solving skills

2. Sound understanding of research methodologies

3. Ability to complete statistical and data analysis

4. Proficient in use of MS Office and statistical tools

5. Knowledge of EO sterilization and validation in accordance with ISO11135

6. Working knowledge of other relevant ISO standards and guidance documents (ISO10993-7, ISO , ISO11138 series, ISO11137 series, EN 1422)

7. Ability to effectively read, write and verbally communicate in English.

8. Ability to work under general direction of a Supervisor or Manager

9. Ability to work autonomously

10. Ability to work well with others.

11. Excellent organizing, analysing and math skills to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.

12. Ability to adapt to changing duties and responsibilities.

13. Normal hearing range sufficient to hear alarms, bells, horns, etc.

This role is responsible for supporting validation activities including develop, support and implementation. In this role, the engineer must ensure qualification activities are performed in accordance with the company's policies and procedures, and regulatory requirements.

Responsibilities:

• Support equipment, facilities, utilities qualifications
• Develop validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and complete execution in a timely fashion,
• Manage qualification execution and lead qualification deviation investigations encountered during qualification
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
• Participate in site Validation Maintenance Program
• Support Change Implementation on site
• Any other tasks as and when assigned by supervisor / Manager
• Support other technical changes and duties as required

About You:

• Engineering/Science Degree or higher from recognised institution
• At least 2 years of experience in Equipment Qualification in the pharmaceutical/biotech industry.
• Experience in Critical Utilities, process equipment and facilities qualification is preferred.
• Must have experience in controlled temperature chamber qualification with temperature mapping.
• Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
• Good Knowledge of Upstream, Downstream and Support Services equipment within the Pharma Biotech Industry.
• Good oral and written communication skills.
• Meticulous and Systematic
• Team player, with strong focus on safety, quality and timeline
• GMP/cGMP knowledge a plus
  Self-motivated and capable of working in diverse team situations with company clients and maintaining a positive attitude towards project challenges.

Duration : 09 months. Option to extend/convert subject to performance review.

Based in Tuas.

VALIDATION ENGINEER

We're hiring a Validation Engineer to ensure our products and processes comply with regulatory and industry standards. The role involves developing and executing validation plans, protocols, and reports for equipment, systems, and processes.

Purpose of Job/Role:

• Assist Quality and Validation Manager Asia to complete the tasks in time with good quality.

• Support company's needs and expectations from Quality and Validation department.

Strategic Priorities/Main Responsibilities:

• Responsible for successful execution the Validation functions for customer project, as required – Quality, Cost, Time.

• Responsible to drive and support project team for projects where validation is required and ensure execution is compliance to Mikron standards.

• Provides training on qualification activities

• Responsible for maintaining qualification documentation standards and procedures.

• Reporting

• Develop project reports as required

• Create reports as necessary

• Ability to follow company and department policies and procedures.

• Adhere to all health and safety rules and procedures

• Any other duties that have been described in detail as assigned by management or supervision within Mikron Group.

Compliance and regulations:

• Must follow all Mikron and customer policies and procedures

• Must follow Mikron Singapore EHS (Environmental/Heathy/Safety) regulations and rules

Qualifications:

• Education: Bachelor's degree/diploma in engineering or equivalent; or at least 5 years related experience and/or training; or equivalent combination of education and experience.

• Minimum 2 years of work experience in quality or validation.

• Work experience in control systems design (design or programming coding) will be an advantage.

• Excellent understanding of shop practices in assembly, test & debug and final acceptance

• Computer skills including Intermediate to advanced working knowledge of MS Excel/Word/PowerPoint with demonstrated record of spreadsheet creation and maintenance.

• Proficient in English (speak, read and write)

Requirements:

• Must be able to travel as requested

• Must be available to work overtime

• May be required to work off shift hours and Holidays

• SINGAPOREAN /PRS ONLY.

We regret that only shortlisted candidates will be notified. Thank you for applying.

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

• Manages Customer Validations ensuring that all validation activities are carried out in compliance with Customer requirements, STERIS policies & procedures, ISO 11135, and ISO 13485, relevant international standards, directives, and regulations.
• Establishes strong Customer relations and provides exceptional Customer service to ensure Customer qualification requirements are met or exceeded throughout all stages of the validation.
• Proactively supports their direct Supervisor to successfully achieve departmental and site objectives and undertake assigned projects.
• Adopts positive cross functional relations. Liaises with quality, operations planning, laboratory and Customer Service to coordinate and progress Customer validations and projects.
• Collaborates with EO TechTeam to support the establishment of best practice approach through knowledge sharing and providing recommendation for EO TechTeam harmonization.

Provides Customer Support & Technical Expertise (30%)

• Applies knowledge and technical expertise to make informed decisions and ensure best practice.
• Collaborates with Customers and provides technical input and recommendations to ensure all aspects of Customer validation requirements are fully considered and can be facilitated.
• Collaborates with Customers throughout all stages of their Validation projects to establish cycle process parameters in line with SEO and in compliance with ISO 11135.
• Liaises with Customers throughout all stages of their validation project, generates and reviews validation protocols, reports and CSPs etc. establishes cycle process parameters in compliance with ISO 11135 and coordinates validation cycles within agreed timelines.
• Seeks advice, support, and input from EO TechTeam, Supervisor or Manager when needed to establish best practice approach.
• Assists in educating and promoting technical solution offering to Customers.
• Collaborates with direct Supervisor to achieve STERIS goals and objectives.
• Actively participates in the exchange of ideas, identifies opportunities for improvement and implements appropriate solutions in line with best practice.

Day to Day Activities (30%)

• With support of direct Supervisor /SVE, manages Customer Validations and all associated documentation in compliance with STERIS Quality Management System, ISO 11135, ISO 13485 and FDA regulatory requirements while adhering to GMP and GDP requirement.
• Performs according to the guidelines outlined in the STERIS Code of Business Conduct. Supports STERIS AST business imperatives of Safety, Quality, Customer Focus, Innovation, Sustainability and Lean.
• Collaborates with all STERIS employees, Customers, auditors, and visitors to the site in a professional, constructive, and respectful manner. Encourages open communication providing timely and accurate responses.
• Sets and agrees annual GPS performance objectives with direct Supervisor. Actively participates in performance management reviews in line with STERIS corporate requirements and timelines.
• Complies with Health and safety polices & procedures, reports any concerns, potential risks or hazards to the Health and Safety representative so appropriate action can be taken.
• With support of direct Supervisor /SVE, collaborates with quality, operations, planning, laboratory, and Customer service to coordinate and progress Customer validations and projects in a timely manner from initiation to completion.
• Actively participates in project Teams and leads projects agreed with direct Supervisor.
• Other site-specific duties and/or additional responsibilities as defined by direct Supervisor.

EO Technical Support & collaboration (15%)

• Supports harmonization and sharing of best practice within the EO TechTeam and across EMEA APAC region to achieve common objectives.
• Complies with and supports their direct Supervisor with the implementation of local and global technical procedures and work instructions applicable to EO TechTeam.
• Collaborates and provides technical support to Customers, regularly interacts with Customers to ensure validation expectations are being met.
• Supports line manager/SVE in Customer meetings and business reviews when required.
• Shares technical expertise and knowledge. Provides input and makes recommendations to ensure best practice approach is employed.
• Provides input and review on local

EO Regulatory Compliance (5%)

• Provides audit support and facilitation as required to the Quality department during internal, Customer and regulatory audits.
• Addresses auditor queries and where necessary interacts directly with auditor with support direct Supervisor /SVE.
• Supports direct Supervisor in the close out of audit findings and recommendations pertaining to EO TechTeam.
• Supports root cause investigations and implementation of appropriate corrective and preventative actions in conjunction with the Quality Manager and site EO TechTeam.

Where required and with support of direct Supervisor /SVE;

• Initiates investigations for non-conforming qualification cycles. In partnership with direct Supervisor and Site Quality Manager identifies, initiates, and implements effective corrective and preventative actions.
• Conducts internal audits of the quality management system, identifies, documents and reports audit findings, observations, recommendations for improvement or non-conformances.
• In compliance with STERIS Quality Management system implements and manages change as per change control procedure.

Training and Development (5%)

• Manages their individual training and development, identifies training and development opportunities, maintains professional skills and knowledge by attending training and development sessions.
• Documents and files training records and certifications.
• Maintains professional skills, knowledge and abilities by attending education workshops, reviewing professional publications and participating in professional forums.

Technology development and Innovation (5%)

• Promotes the advancement of the STERIS SEO program through activities such as Cycle Calculation and/or Parametric Release.
• Educates Customers and recommends/promotes suitable technical solution offering with support of direct Supervisor /SVE.
• Supports EO focussed R&D initiatives and provides support, technical input or expertise as required.

Continuous Improvement (5%)

• Actively participates in STERIS ongoing 5S, lean and continuous improvement initiatives. Supports the EO TechTeam in identifying and implementing improvement initiatives.
• Identifies lean and continuous improvement opportunities and where feasible initiates or supports plan to implement improvement.

Performance Qualification, annual requalification and calibration/verification of dataloggers (5%)

Where applicable to the role or EO Technical department, with support of direct Supervisor /SVE;

• Assists with the launching, downloading, analysis, registration, verification, and calibration of data loggers to ensure sufficient stock of dataloggers are available to support ongoing validation requirements.
• Coordinates the calibration and maintenance of EO Technical related equipment to ensure calibration is maintained within date and equipment operates as intended.
• Schedules, documents and coordinates commissioning and recommissioning of assigned sterilisation chambers.

Bachelor's Degree in Engineering General or Science

Diploma/Degree in life-science or Engineering with a minimum of 1 years industrial experience with knowledge of ISO13485, process validation and Microbiological/chemical testing. Knowledge of EO sterilisation process and ISO 11135 desirable.

In lieu of meeting the minimum educational requirement applicants with a minimum of 3 years industrial experience preferably in EO sterilisation, demonstrating strong technical skills with comprehensive working knowledge of quality standards ISO11135 and ISO13485 process validation and Microbiological/chemical testing associated with the EO sterilisation process will be considered.

Work Requirements

1. Strong technical writing, scientific writing and problem-solving skills
2. Sound understanding of research methodologies
3. Ability to complete statistical and data analysis
4. Proficient in use of MS Office and statistical tools
5. Knowledge of EO sterilization and validation in accordance with ISO11135
6. Working knowledge of other relevant ISO standards and guidance documents (ISO10993-7, ISO , ISO11138 series, ISO11137 series, EN
7. Ability to effectively read, write and verbally communicate in English.
8. Ability to work under general direction of a Supervisor or Manager
9. Ability to work autonomously
10. Ability to work well with others.
11. Excellent organizing, analysing and math skills to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
12. Ability to adapt to changing duties and responsibilities.
13. Normal hearing range sufficient to hear alarms, bells, horns, etc.

Pay rate for this opportunity is $(INSERT). This position is incentive plan eligible, at target earnings of $(INSERT RANGE), depending on performance.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit

If you need assistance completing the application process, please call This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours.

Position: Validation Engineer

We are Coalesce Management Consulting - a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

We are currently expanding our team and are looking for a Validation Engineer to support projects on-site with a client.

Key Responsibilities:

• Prepare and execute validation protocols (URS, IOQ, PQ, FMEA, PVP) for equipment such as CIP tanks, robotic cleaners, and utility systems
• Conduct cleaning validation, temperature mapping, and requalification activities
• Ensure timely delivery of validation documentation and compliance with project timelines
• Develop and review qualification documentation (DQ, IQ, OQ, PQ, SAT, QSR) in both paper-based and digital platforms (KNEAT)
• Support validation of chemical production systems and cleanroom equipment
• Coordinate equipment change releases and ensure timely CR closures

Requirements:

• Degree related to Science or Engineering.
• Good knowledge and experience in GMP facilities.
• At least 5 years of experience in manufacturing, and biopharmaceutical industries.
• Ability to multitask and work in a fast-paced environment with competing priorities.
• Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels.
• Exhibit continuous improvement mindset and innovative thinking

What's in it for you?

• Greatest exposure to the Big Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

If you are interested in applying for this position, please send an email to

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.

The Opportunity

Esco Lifesciences Group is Singapore's most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.

Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.

The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.

The Scope

You will be part of Esco Aster's MSAT team and contribute to the overall site mission and objectives. You will ensure Commissioning Qualification and Validation (CQV) activities and tasks are planned and executed in an efficient and compliant manner, while adhering to GxP standards. You will work with the Leadership team of MSAT to develop a continuous improvement mindset and engage in teamwork with cross-functional departments.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

· Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities and processes.

· Develop validation protocols and reports that fulfil regulatory requirements and industry best practices.

· Assist in developing User Requirements Specification documents.

· Prepare design review and design qualification documents at the initial design stage to align with specifications.

· Generate protocols and execute field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ).

· Prepare and execute FMEA and validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation and Transport Qualification, as required.

· Complete assigned CQV tasks according to planned schedule, budget, safety and engineering standards.

· Coordinate with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives.

· Coordinate and manage external parties, primarily vendors and contractors to achieve CQV objectives.

· Investigate deviations and write deviation reports and findings.

· Support Engineering and Facilities functions as needed.

· Undertake tasks assigned by leaders as and when appropriate.

Requirements

· Degree and/or Diploma in Engineering/Science or related studies.

· Minimum of 1-3 years' experience in pharmaceutical/biopharmaceutical manufacturing facility.

· Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.

· Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.

· Competent in technical writing and presentations.

· Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).

· Able to work independently, self-starter, self-motivated and task oriented.

· Good communication skills and able to openly communicate and escalate any relevant issues.

· Strong team player to work with both internal and external stakeholders.

· Develop positive relationship with a strong set of interpersonal skills.

· Prepared to travel and reside abroad to ensure the successful execution of external projects, if required.

Interested candidates, please submit a Cover Letter and CV to

Si Validation Engineer :

• Programming language – C & Python
• Good Understanding of SOC architectures and validation of Integrated IP's
• Test plan development and test content writing based on design specifications, architecture document & end use case scenarios for SOC's
• Silicon bring up, initial power-on, bootup & functional testing
• Preferred Memory & PCIE validation experience
• Virtualization as added advantage
• Knowledge of RocM framework
• Debug and root cause analysis for complex SOC's in post Silicon test phase.
• Automation and test infrastructure development for automated testing post power-on

We are looking for an experienced Validation Engineer to support the Commissioning, Qualification, and Validation (CQV) activities for an ongoing fill-finish expansion project. This mid-level role will involve executing qualification protocols, supporting commissioning activities, and ensuring all systems (utility and process equipment) meet the required regulatory and operational standards.

• Execution of Qualification Protocols: Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for utility systems (e.g., HVAC, WFI, purified water, compressed air) and process equipment (e.g., filling lines, capping systems, packaging equipment).
• Commissioning Support: Assist in commissioning activities for systems and equipment, ensuring adherence to specifications, regulations, and operational requirements.
• Documentation: Ensure that all validation documentation is accurate, complete, and in compliance with GMP and regulatory requirements. Review and approve qualification reports, test results, and associated documentation.
• Deviation Management: Support the investigation and resolution of any deviations identified during the qualification process and ensure proper documentation of corrective actions.
• Cross-Functional Collaboration: Work closely with engineering, operations, and quality assurance teams to ensure a smooth validation process and meet project timelines.
• System Monitoring: Track progress and maintain a system to monitor and report validation status and compliance during the C&Q phase.
• Training and Support: Provide support and guidance to junior validation engineers and help with training on validation activities and protocols.

• Education: Bachelor's degree in Engineering (Mechanical, Chemical, Biochemical, or related field).
• Experience: Minimum of 5 years of experience in validation, commissioning, and qualification within pharmaceutical or biotech environments.
• Technical Skills:
  
  Strong hands-on experience with utility systems (WFI, HVAC, purified water, compressed air) and process equipment (filling, capping, and packaging systems).
  
  Solid understanding and experience with IQ/OQ/PQ protocols.
  
  Familiar with GMP and GxP regulations and their application to qualification activities.
• Attention to Detail: Ability to ensure the thorough execution of qualification protocols and proper documentation of deviations and corrective actions.
• Communication Skills: Good written and verbal communication skills to work with project teams and document validation results.