Senior CQV Engineer: GMP Validation & Compliance

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 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