958 Validation Engineer jobs in Singapore

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.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.

Position Overview

We are looking for a Validation Engineer to manage and execute validation activities, including equipment, utilities, and facility qualifications. You will develop and support the creation of validation documentation, apply a science-based approach to validation, analyze data, and assist with investigating deviations. Collaboration with cross-functional teams and adherence to safety, quality, and regulatory standards are key aspects of this role to ensure the successful delivery of validation projects.

Key Responsibilities

• Develop, execute, and document protocols (IQ, OQ, PQ) and reports for new qualification.
• Coordinate the completion of cleaning performance qualification.
• Investigate and resolve discrepancies/incidents arising from qualification activities.
• Perform Periodic review Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
• Support change control activities, ensuring proper validation assessments and documentation.
• Support other day-to-day validation activities, ensuring adherence to approved Validation SOPs, Plans, and Policies.
• Work closely with End-Users, Quality, and Engineering functions to ensure validation activities are completed as planned.

Required Qualifications

• Fair knowledge and experience of the practical and theoretical requirement of validation program in a GMP facility.
• Relevant experience in validation of facility, equipment, utility, cleaning, and/or sterilization.
• Familiarity with Regulatory requirements and Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
• Ability to read and interpret technical documentation, system specifications, and validation protocols.
• Strong analytical, problem-solving, and organizational skills.
• Excellent communication skills and ability to work in a team-oriented environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Willingness to learn and adapt in a fast-paced, regulated industry.

Why join us?

• Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

• 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.

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.

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

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.

• 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

• 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
• Preferred Six Sigma black and green belt certified as it is mandatory for the project prerequisite.
• GMP & GDP Certificate is mandatory
• Well versed with Regulatory Guidelines - USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP , GAMP5, ISO, WHO etc.

• 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

• 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 , GAMP5, ISO, WHO etc

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