Senior CQV Engineer-BioPharma

PHARMENG TECHNOLOGY PTE. LTD.; Singapore; On-site; SGD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive wages

Travel opportunities

Team-oriented culture

Job summary

PharmEng Technology in Singapore seeks an experienced Commissioning, Qualification and Validation (CQV) Engineer to lead qualification activities for GMP pharmaceutical projects. You will draft and execute CQV documentation, work with QC SMEs on equipment qualification, and coordinate vendor IOQs to ensure timelines and quality.

Responsibilities include managing deviations, risk assessments, CAPA, and ensuring data integrity and regulatory compliance while collaborating with stakeholders across

Qualifications

• 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.

Responsibilities

• Draft, review and execute CQV documentation (PLAN/CVPR, CQ, DIA, SA, QSR/CVSR).
• Collaborate with QC SMEs to capture user requirements and qualify equipment.
• Coordinate vendor IOQs and ensure alignment with site standards and timelines.
• Support deviation management, change control and CAPA related to CQV projects.
• Contribute to continuous improvement of CQV processes and data integrity.

Skills

CQV experience

Regulatory knowledge

Technical writing

Coordination & stakeholder management

Education

Bachelor's degree in Engineering or Life Sciences

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.