Pharmaceutical CQV Engineer

Responsibilities

Lead and execute commissioning, qualification, and validation (CQV) activities for pharmaceutical equipment, utilities, and systems.

Prepare and review CQV documentation, including protocols (IQ/OQ/PQ), reports, and risk assessments.

Ensure compliance with GMP, FDA, EMA, and other global regulatory standards.

Collaborate with cross‑functional teams including QA, Engineering, Manufacturing, and Project Management.

Troubleshoot systems and support investigations for deviations and non‑conformances.

Participate in FAT/SAT execution and system handover processes.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related field.

Proven experience in CQV within pharmaceutical or biotech manufacturing environments.

Strong knowledge of GMP regulations and industry standards (ISPE, ASTM E2500, etc.).

Experience with equipment and systems such as clean utilities, HVAC, autoclaves, lyophilizers, and bioreactors.

Excellent documentation, problem‑solving, and analytical skills.

Ability to work independently and collaboratively in a highly regulated environment.

Benefits

An international community bringing together more than 110 different nationalities.

An environment where trust is central: 70% of our leaders started their careers at the entry level.

A strong training system with our internal Academy and more than 250 modules available.

A dynamic work environment that frequently comes together for internal events.

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

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