Senior CQV Engineer

We are seeking a skilled Senior CQV Engineer to lead commissioning, qualification, and validation activities for new and existing systems in compliance with industry regulations. The role involves developing and executing validation protocols, ensuring systems and equipment meet required standards, and collaborating with cross-functional teams to support project delivery. The ideal candidate has strong expertise in pharmaceutical or biotechnology environments, with a focus on GMP compliance.

Key Responsibilities:

1. Lead commissioning, qualification, and validation (CQV) activities for equipment, utilities, and systems.
2. Develop and execute IQ/OQ/PQ protocols to ensure compliance with regulatory requirements.
3. Perform risk assessments and ensure validation processes meet GMP standards.
4. Collaborate with project teams to deliver compliant and efficient systems.
5. Troubleshoot and resolve CQV-related issues and deviations.

Qualifications:

1. Bachelor’s degree in Engineering, Life Sciences, or a related field.
2. 5+ years of experience in CQV within pharmaceutical, biotech, or similar industries.
3. Strong knowledge of GMP, FDA, and industry regulations.
4. Experience with IQ/OQ/PQ protocols and validation lifecycle management.
5. Excellent problem-solving and communication skills.

MUST be able to work in the US without restriction to duration of time.

Open to relocation.