Senior Pharmaceutical CQV Engineer

Become a key player at Amaris Consulting as a Senior Pharmaceutical CQV Engineer, leading commissioning and validation projects in a highly regulated environment. Your expertise in compliance and team collaboration will drive success.

Candidates should possess a Bachelor’s degree in Engineering or a related Life Sciences field, along with demonstrated experience in CQV activities within pharmaceutical or biotech sectors. You will prepare and review critical documentation while ensuring compliance with all GMP and regulatory standards, including FDA and EMA. Your ability to troubleshoot and support investigations will be vital for maintaining system integrity and compliance.

Key Responsibilities:

• Lead CQV activities for pharmaceutical equipment and systems

• Prepare and review documentation, including protocols and risk assessments

• Ensure adherence to GMP and other regulations

• Collaborate effectively across functions: QA, Engineering, and Manufacturing

• Participate in FAT/SAT execution and resolve deviations

Requirements:

• Bachelor’s degree in Engineering or Life Sciences

• Experience in CQV for pharmaceutical manufacturing

• In-depth knowledge of GMP regulations

• Familiarity with bioreactors and clean utilities

• Strong problem-solving and documentation skills

Drive your CQV expertise forward at Amaris Consulting as you ensure compliance and success.
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