934 Pharmaceutical Engineer jobs in Singapore

Validation Engineer

Join our team as a Validation Engineer and play a key role in ensuring our products and processes meet the highest standards of quality and compliance. This position offers exposure to diverse projects and the opportunity to collaborate across regional teams.

Purpose of the Role

• Support the Quality and Validation Manager Asia in delivering timely and high-quality outcomes.
• Contribute to the department's goals while aligning with company expectations.

Key Responsibilities

• Lead and execute validation activities for customer projects, ensuring alignment with quality, cost, and timeline objectives.
• Collaborate with project teams to ensure validation processes meet Mikron standards.
• Conduct training sessions on qualification activities.
• Maintain documentation standards and procedures for qualification.
• Prepare and present project reports as needed.
• Comply with company policies, procedures, and safety regulations.
• Perform other duties as assigned within the Mikron Group.

Compliance & Regulations

• Adhere to Mikron and customer-specific policies.
• Follow Mikron Singapore's EHS (Environmental, Health & Safety) guidelines.

Qualifications & Skills

• Bachelor's degree/diploma in engineering or equivalent, or 5+ years of relevant experience.
• Minimum 2 years of experience in quality or validation.
• Experience in control systems design (design or programming) is a plus.
• Strong understanding of shop practices in assembly, testing, debugging, and final acceptance.
• Proficient in MS Excel, Word, and PowerPoint.
• Fluent in English (spoken and written).

Additional Information

• Flexibility to travel occasionally for project or training needs.
• Willingness to support critical project timelines, which may include extended hours or special scheduling.
• Availability during peak periods, including weekends or public holidays, may be required—with appropriate time-off benefits provided.

Eligibility

• Open to Singapore Citizens and Permanent Residents only.

We appreciate your interest and regret that only shortlisted candidates will be contacted.

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

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.

Introduction

We at Traque are on an exciting journey of growth and are looking for a dynamic Validation Engineers to help us achieve our vision to become "your first-choice industrial solution provider".

Traque provides comprehensive consulting and engineering solutions, working with multinational pharmaceutical clients to R&D facilities - across all spectrums of the industry from chemical API, secondary, biopharmaceutical to medical device designers and manufacturers.

Key Duties:

The Validation Engineers are responsible for validation of biopharmaceutical equipment, facilities, utilities, laboratory equipment and computer systems in new and modified pharmaceutical and life science facilities. This includes working or leading a team, supporting the purchase, installation, commissioning and qualification of biopharmaceutical equipment, utilities and processes.

• Sourcing, specification and selection of new equipment based on minimal user input
• Coordinating with vendors and working with the design teams to ensure a fit for purpose system
• Managing installation and commissioning of the equipment (with vendor support)
• Qualification of the equipment, including: - preparation of protocols and test plans, execution of the protocols including sample and reagent preparation, preparation of qualification summary reports, and investigation of deviations
• Supporting process technical transfer: - including feasibility studies, equipment sizing, process design, process validation and process optimisation
• User training in equipment use and operation
• Supporting cleaning and process validation studies, including cleaning strategy development, protocol development, execution assistance

Job Requirements

• University degree in Engineering, Life Sciences or equivalent
• Minimum 3 years' experience in commissioning and/or validation of biopharmaceutical equipment and processes
• Experienced working in a pharmaceutical or GMP/GLP environment is preferred, although cross-industry expertise is welcomed
• Preferably experienced with using Kneat
• Experienced working under Quality Management Systems
• Excellent interpersonal and communication skills
• Goal-oriented, dynamic, and high sense of responsibility
• Able to work flexibly and under pressure
• Able to work self-reliantly
• Possess excellent customer-oriented work-ethic
• Professional appearance and demeanor
• Very good written and verbal English skills
• Immediate availability is preferred

Introduction
We at Traque are on an exciting journey of growth and are looking for a dynamic
Validation Engineers
to help us achieve our vision to become "your first-choice industrial solution provider".
Traque provides comprehensive consulting and engineering solutions, working with multinational pharmaceutical clients to R&D facilities - across all spectrums of the industry from chemical API, secondary, biopharmaceutical to medical device designers and manufacturers.
Key Duties:
The Validation Engineers are responsible for validation of biopharmaceutical equipment, facilities, utilities, laboratory equipment and computer systems in new and modified pharmaceutical and life science facilities. This includes working or leading a team, supporting the purchase, installation, commissioning and qualification of biopharmaceutical equipment, utilities and processes.
Sourcing, specification and selection of new equipment based on minimal user input
Coordinating with vendors and working with the design teams to ensure a fit for purpose system
Managing installation and commissioning of the equipment (with vendor support)
Qualification of the equipment, including: - preparation of protocols and test plans, execution of the protocols including sample and reagent preparation, preparation of qualification summary reports, and investigation of deviations
Supporting process technical transfer: - including feasibility studies, equipment sizing, process design, process validation and process optimisation
User training in equipment use and operation
Supporting cleaning and process validation studies, including cleaning strategy development, protocol development, execution assistance
Job Requirements
University degree in Engineering, Life Sciences or equivalent
Minimum 3 years' experience in commissioning and/or validation of biopharmaceutical equipment and processes
Experienced working in a pharmaceutical or GMP/GLP environment is preferred, although cross-industry expertise is welcomed
Preferably experienced with using Kneat
Experienced working under Quality Management Systems
Excellent interpersonal and communication skills
Goal-oriented, dynamic, and high sense of responsibility
Able to work flexibly and under pressure
Able to work self-reliantly
Possess excellent customer-oriented work-ethic
Professional appearance and demeanor
Very good written and verbal English skills
Immediate availability is preferred
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Boon Lay Way, Singapore | Posted on 04/07/2025
Process RQs (SIP, Bulk Sterilization, Autoclave)
Warehouse mapping
Filtration skids
Trending of Results
Develop, review, and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, completed in a timely fashion.
Lead project validation activities and provide basic guidance and direction to junior project engineers as required.
Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
Manage qualification execution and lead validation deviation investigations encountered in qualification.
Collaborate with multiple functions to arrange, plan, and ensure the smooth running of qualification activities.
Able to manage cross-functional stakeholders, and to lead/facilitate meetings and discussions relevant to project qualification/validation activities.
Participate in site Validation Maintenance Program.
Support Change Implementation on site.
Any other tasks as assigned by Supervisor or Project Lead.
Requirements
Preferably 10 years and above of experience for a senior role.
3-5 years of experience in a mid-level role.
0-3 years of experience in a junior role.
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Join to apply for the Validation Engineer role at STERIS.
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.
Overview
Position Summary
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.
Duties
Responsible to provide 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.
Education
Bachelor's Degree in Engineering General or Science
Required Experience
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
Strong technical writing, scientific writing and problem-solving skills
Sound understanding of research methodologies
Ability to complete statistical and data analysis
Proficient in use of MS Office and statistical tools
Knowledge of EO sterilization and validation in accordance with ISO11135
Working knowledge of other relevant ISO standards and guidance documents (ISO10993-7, ISO 11737-1, ISO11138 series, ISO11137 series, EN 1422)
Ability to effectively read, write and verbally communicate in English.
Ability to work under general direction of a Supervisor or Manager
Ability to work autonomously
Ability to work well with others.
Excellent organizing, analysing and math skills to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
Ability to adapt to changing duties and responsibilities.
Normal hearing range sufficient to hear alarms, bells, horns, etc.
STERIS is an Equal Opportunity Employer.
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Join to apply for the
Validation Engineer
role at
PSC Biotech Corporation .
Responsibilities include:
Process RQs (SIP, Bulk Sterilization, Autoclave)
Warehouse mapping
Filtration skids
Trending of Results
Develop, review, and approve validation lifecycle documents, protocols, and reports in accordance with policies, standards, procedures, and guidelines, completing tasks in a timely manner.
Lead validation activities and provide guidance to junior engineers.
Review Turnover/Vendor Packages to support qualification activities.
Manage qualification execution and lead deviation investigations.
Collaborate with multiple functions to plan and ensure smooth qualification activities.
Manage stakeholders and facilitate meetings related to validation activities.
Participate in site Validation Maintenance Program.
Support Change Implementation on site.
Perform other tasks as assigned by Supervisor or Project Lead.
Additional tasks include:
Utilities RQ (WFI)
Process RQs (SIP, Bulk Sterilization, Autoclave)
Cleaning validation
Warehouse mapping
Filtration skids
Mixing tank
Washer qualification
Trending of Results
Data mining
LIMS queries
Requirements
Preferably 10+ years of experience for senior role
3-5 years of experience in mid-level role
0-3 years of experience in junior role
Additional Information
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
This job posting is active and open for applications.
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Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Lonza Singapore belongs to the Biologics business unit and plays a critical role in supporting GMP manufacturing operations for biopharmaceutical products. The Engineering team ensures smooth, reliable, and compliant operation of equipment and facilities to support the production of life-saving medicines.
As a
Validation
Engineer , you will support the validation of computerized systems in a Good Manufacturing Practice (GMP) pharmaceutical environment, ensuring compliance with regulatory requirements and industry best practices. You will work closely with cross-functional teams, including Engineering, Quality, Automation, and IT, to validate systems that support manufacturing, laboratory, and business processes. Our ambitious vision is to successfully implement innovative solutions that make a positive difference. If you have the determination to inspire change, this is the role for you.
What you will get
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
Daily company bus from the MRT location near your home to and from the Tuas site
Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums
Opportunities to drive continuous improvement in a high-impact environment
What you will do
Supports computerized system validation (CSV) activities for GMP-regulated systems, including manufacturing, laboratory, and business applications.
Perform day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies
Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation / closure
Collaborate with vendors and other Engineering functions to perform technical evaluation of the new equipment or modification, so as to develop appropriate protocol that will demonstrate that the equipment or modification meet the user or project requirements
Participate in system design review to ensure compliance to user requirements, good engineering practice, validation requirements and regulatory standards
Collaborate with other Engineering functions, End-User and Quality team to ensure the Validation activities are completed as planned
Review Engineering documents associated with commissioning and validation activities
Participate in Site Validation Maintenance Program
Participate in commissioning activities when required
Support Change Implementation on site
Support for customer and regulatory audit / inspections as required
What we are looking for
Degree in Engineering (Mechanical, Chemical, Biomedical, etc).
Strong experience in computerized system validation (CSV) or automation in GMP regulated industry.
Good understanding of regulations and industry standards relating to computerized system including data integrity principles.
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.
Willingness to learn and adapt in a fast-paced, regulated industry.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world — the satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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