
CQV Engineer
14 hours ago
Our client is seeking a CQV Engineer (Commissioning, Qualification & Validation) to join their team.
Are you ready to play a crucial role in the pharmaceutical industry? Join a dynamic team as a CQV Engineer, where you\'ll support the start-up and validation of cutting-edge pharmaceutical and biotech manufacturing facilities. This opportunity offers the chance to work with state-of-the-art technology, collaborate with cross-functional teams, and ensure GMP compliance for commercial production.
Overview
Role: CQV Engineer focused on commissioning, qualification, and validation for pharmaceutical/biotech manufacturing facilities, utilities, and process equipment. This position requires ensuring GMP compliance and alignment with project timelines.
Responsibilities
Plan and execute CQV activities: Lead commissioning, qualification, and validation efforts for pharmaceutical/biotech manufacturing facilities, utilities, and process equipment.
Develop protocols: Create and review CQV protocols (IQ/OQ/PQ) and reports, ensuring compliance with GMP, GAMP 5, and company procedures.
Collaborate across teams: Work closely with engineering, project, and quality teams to ensure timely CQV execution and resolve issues.
Ensure regulatory compliance: Maintain adherence to FDA, EMA, PIC/S, and local health authority guidelines throughout the CQV process.
Provide technical expertise: Offer input during design, construction, and operational readiness stages, contributing to project success.
Qualifications
Educational background:
A Bachelor\'s degree in engineering, Life Sciences, or a related field.
Industry experience:
2-5 years in commissioning/qualification/validation within pharmaceutical or biotech industries; senior roles may require 5+ years.
Regulatory knowledge:
Familiarity with GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulations.
Hands-on experience:
Practical experience with utilities (e.g., WFI, clean steam, HVAC), process equipment, or cleanroom systems is preferred but not mandatory.
Communication skills:
Strong ability to communicate effectively and coordinate projects.
Benefits
Attractive remuneration package and other benefits
Comprehensive medical insurance coverage
Generous annual leave of at least 14 days
Opportunity to work in a rapidly growing industry with cutting-edge technology
How to apply
Ready to join this role? Click Apply now to submit your resume and share your availability and expected salary. We encourage all qualified individuals to apply, regardless of background or experience level. Your unique perspective could be exactly what we\'re looking for
All information received will be kept strictly confidential and will be used only for employment-related purposes.
EEO statement and related disclosures as applicable.
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