CQV Engineer

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 exciting opportunity offers the chance to work with state-of-the-art technology, collaborate with cross-functional teams, and ensure GMP compliance for commercial production.

What you'll be doing?

• 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 any issues that arise.
• Ensure regulatory compliance: Maintain adherence to FDA, EMA, PIC/S, and local health authority guidelines throughout the CQV process.
• Provide technical expertise: Offer valuable input during design, construction, and operational readiness stages, contributing to the overall success of projects.

Who are they looking for?

• Educational background: A Bachelor's degree in engineering, Life Sciences, or a related field, providing a strong foundation for the role.
• Industry experience: 2-5 years of experience in commissioning/qualification/validation within pharmaceutical or biotech industries, with senior roles potentially requiring 5+ years.
• Regulatory knowledge: Familiarity with GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulations, essential for ensuring compliance.
• 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, crucial for success in this collaborative role.

Why you should consider this opportunity?

Our client offers an attractive remuneration package and other benefits, such as:

• 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 with us

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.

Jobs DB Singapore Pte Ltd | 24C2640

Oh Zi Yi, Joey | R

SmartHire

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