CQV Engineer
Job Summary
The CQV Engineer is responsible for supporting commissioning, qualification, and validation activities for GMP process equipment and utilities within pharmaceutical or biotechnology environments. The role focuses on stainless steel vessels, CIP/SIP systems, thermal systems, and related utilities. Key tasks include preparing, executing, and reviewing CQV documentation in compliance with GMP, GDP, and project standards.
Responsibilities
- Prepare and execute IQ/OQ/PQ protocols and CQV documentation
- Perform qualification for stainless steel vessels and process equipment
- Conduct CIP/SIP and thermal mapping verification
- Manage deviations, punch items, and non-conformities
- Review technical documents including P&IDs and datasheets
Required Skills
- 3-5 years of CQV experience in GMP environments
- Proficiency with Kneat validation software
- Strong knowledge of GMP, GDP, and data integrity
- Ability to read P&IDs and equipment drawings
- Experience with CIP/SIP and material certification
Job Details
Position Overview
The CQV Engineer is responsible to support commissioning, qualification and validation activities for GMP process equipment and utilities in a pharmaceutical / biotechnology environment. Focus on equipment such as stainless steel vessels, CIP/SIP systems, thermal systems and related process utilities. Prepare, execute, review and close CQV documentation in line with GMP, GDP and project requirements.
Key Responsibilities
- Prepare and execute CQV documents, including: Commissioning protocols, IQ / OQ / PQ protocols, Test scripts, Qualification reports, Deviation reports, Traceability matrices
- Support qualification of stainless steel vessels, including: Mixing vessels, Holding tanks, Buffer / media preparation vessels, Process tanks, Product-contact equipment
- Perform Material of Construction checks for stainless steel equipment, including verification of: MOC certificates, Surface finish, Welding documentation, Passivation records, Product-contact parts, Gasket / seal materials
- Support CIP and SIP qualification, including: Cycle verification, Sprayball coverage checks, Flow / pressure / temperature verification, Conductivity checks, Hold time verification, Drainability checks, Sterilisation cycle assessment
- Support thermal mapping / temperature qualification activities for GMP equipment and systems.
- Execute qualification testing and document results in accordance with approved protocols.
- Use Kneat for protocol execution, review, comment resolution and document lifecycle management.
- Support FAT / SAT, commissioning walkdowns and system handover activities.
- Review vendor documents, drawings, P&IDs, datasheets, manuals and calibration records.
- Raise and support closure of deviations, punch items, non-conformities and qualification discrepancies.
- Work with QA, Engineering, Manufacturing, Automation, Vendors and Project teams to ensure timely CQV completion.
- Ensure all qualification activities comply with GMP, GDP, data integrity and site SOP requirements.
Required Qualifications
- Degree / Diploma in Engineering, Biotechnology, Pharmaceutical Science, Life Sciences or related discipline.
- 3 to 5 years of relevant CQV experience in pharmaceutical, biotech, biologics or GMP manufacturing environment.
- Hands-on experience with CIP, SIP, thermal mapping and stainless steel process equipment.
- Experience performing Material of Construction checks for GMP equipment.
- Familiar with IQ / OQ / PQ execution and GMP documentation requirements.
- Experience using Kneat for validation document execution and review.
- Able to read and understand P&IDs, equipment drawings, datasheets and vendor technical documents.
- Good understanding of GMP, GDP, deviation management and change control.
- Strong documentation discipline and attention to detail.
- Able to work independently on site and coordinate with cross-functional teams.