Senior CQV Engineer-BioPharma

PharmEng Technology; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

PharmEng Technology in Singapore is seeking an experienced Commissioning, Qualification and Validation (CQV) Engineer to support GMP projects in the Life Sciences sector. You will draft and execute CQV documentation, coordinate vendor activities, and ensure compliance with GDP, GxP and regulatory guidelines.

Key duties include collaboration with QC SMEs, defining qualification strategies, and driving continuous improvement while upholding data integrity and cybersecurity during system

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Experience in CQV in a regulated (GMP) pharmaceutical/biopharma environment.
• Knowledge of regulatory guidelines (FDA, EMA, ICH, ISPE, GAMP 5).
• Strong technical writing, analytical, and problem-solving skills.
• Excellent coordination, communication, and stakeholder management abilities.

Responsibilities

• Draft, review, and execute CQV documentation, including plans, CQV protocols, DIA, SA, and QSR/CVSR.
• Ensure documentation complies with GDP, GxP, and regulatory guidelines.
• Maintain records of test execution and deviations.
• Collaborate with QC SMEs to capture user requirements for equipment qualification.
• Define qualification strategies in alignment with project and regulatory requirements.
• Liaise with equipment vendors to review IOQ documentation and review vendor-supplied materials.
• Coordinate execution of vendor IOQs and resolve technical or compliance issues.
• Ensure vendor activities align with site standards and project timelines.
• Support deviation management, change control, and CAPA activities related to qualification and commissioning.
• Contribute to continuous improvement initiatives to streamline CQV processes and enhance efficiency.
• Ensure adherence to data integrity principles and cybersecurity requirements during system qualification.

Skills

Technical writing

Analytical thinking

Problem solving

Coordination/communication

Stakeholder management

Education

Bachelor’s degree in Engineering, Life Sciences, or related discipline

Job description

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Commissioning, Qualification and Validation (CQV) Engineer with experience in pharmaceutical company/Life Science industries for a role in Singapore.

Key Responsibilities:

Documentation & Execution

• Draft, review, and execute Commissioning and Qualification (C&Q) documentation, including Qualification Plans (PLAN/CVPR), Commissioning and Qualification Protocols (CQ), Data Integrity Assessments (DIA), Security Assessments (SA), and Qualification Summary/Completion Reports (QSR/CVSR).
• Ensure all documentation complies with Good Documentation Practices (GDP), GxP, and regulatory guidelines.
• Maintain accurate records of test execution and deviations.

Equipment & Systems Qualification

• Collaborate with Quality Control (QC) Subject Matter Experts (SMEs) to capture and align user requirements for the qualification of new laboratory and production equipment.
• Participate in risk assessments and define qualification strategies in alignment with project and regulatory requirements.

Vendor & Stakeholder Coordination

• Liaise with equipment vendors and service providers to review, assess, and approve vendor-supplied documentation such as Installation and Operational Qualification (IOQ) protocols.
• Coordinate execution of vendor IOQs and support resolution of technical or compliance issues.
• Ensure vendor activities align with site standards and project timelines.

Compliance & Continuous Improvement

• Support deviation management, change control, and CAPA activities related to qualification and commissioning projects.
• Contribute to continuous improvement initiatives to streamline CQV processes and enhance efficiency.
• Ensure adherence to data integrity principles and cybersecurity requirements during system qualification.

Qualifications & Skills:

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Experience in Commissioning, Qualification, and Validation (CQV) in a regulated (GMP) pharmaceutical/biopharma environment.
• Knowledge of regulatory guidelines (FDA, EMA, ICH, ISPE, GAMP 5).
• Strong technical writing, analytical, and problem-solving skills.
• Excellent coordination, communication, and stakeholder management abilities.

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world‑class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

EEOC Statement

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.