CQV Engineer
Job Summary
The CQV Engineer will lead commissioning, qualification, and validation activities for facilities and equipment in compliance with GMP standards. This role involves developing validation strategies, managing FAT/SAT processes, and ensuring technical systems meet regulatory requirements. You will also oversee technical deviations and support internal and external audits to maintain operational excellence.
Responsibilities
- Lead CQV activities for GMP facilities and equipment
- Develop and execute DQ, IQ, OQ, and PQ strategies
- Manage FAT/SAT and cross-functional project timelines
- Perform root cause investigations and manage CAPAs
- Support audits and ensure regulatory documentation compliance
Required Skills
- Degree in Engineering or Scientific field
- Experience in Pharmaceutical/Chemical plant environment
- Deep knowledge of GMP and HSE practices
- Proficiency in technical documentation and MS Office
- Strong English communication skills
Job Details
Responsibilities:
- Lead Commissioning, Qualification and Validation (CQV) activities for facilities, equipment, utilities, and systems in compliance with GMP and regulatory requirements.
- Develop and execute CQV strategies, including DQ, IQ, OQ, and PQ, ensuring validation readiness and successful project delivery.
- Plan and manage commissioning activities, including FAT and SAT, coordinating cross-functional dependencies and project timelines.
- Lead qualification of critical GMP utilities such as HVAC, purified water, compressed air, and related systems.
- Assess new or modified systems within change control processes to define qualification strategies and documentation scope.
- Execute commissioning and IQ protocols, ensuring systems are compliant, functional, and operationally ready.
- Coordinate and manage external vendors for testing, execution, and analytical activities.
- Manage technical deviations, perform root cause investigations, and lead the implementation of CAPAs.
- Ensure accurate registration of equipment and instruments in SAP, aligned with maintenance and calibration plans.
- Support audits and inspections by ensuring documentation readiness and compliance with GMP, FDA, and ICH guidelines.
Qualifications:
- University degree, or equivalent qualification in Engineering or similar scientific field.
- Relevant experience in installation management or equipment qualification and automation, preferably with a focus in chemical plants or Pharmaceutical industry.
- Training and experience of GMP and HSE practices.
- Relevant understanding and knowledge of legislation applicable to engineering projects and quality requirements applicable to technical installations.
- Competent (written and verbal) English.
- Computer literate with good working knowledge of the MS Office package.
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.