CQV Engineer - Katalyst Healthcares & Life Sciences

Responsibilities:

• We are seeking experienced CQV (Commissioning, Qualification, and Validation) Engineers with a strong pharmaceutical background to join our team in Pennington, NJ.

• The ideal candidate must be ready to work fully onsite and possess deep expertise in CQV processes, specifically within the pharmaceutical industry.

• This role will involve ensuring that all systems and equipment are properly commissioned, qualified, and validated according to industry standards and regulatory requirements.

• Conduct commissioning, qualification, and validation activities for pharmaceutical manufacturing equipment and systems.

• Develop and execute protocols for IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification).

• Collaborate with cross-functional teams, including Engineering, Quality, and Manufacturing, to ensure compliance with GMP and regulatory standards.

• Document all CQV activities, including deviations and corrective actions, in accordance with company and regulatory guidelines.

• Support the implementation and validation of new systems, equipment, and processes.

• Participate in risk assessments and ensure proper mitigation strategies are in place.

• Provide technical support during audits and inspections.

Requirements:

• Proven experience as a CQV Engineer in the pharmaceutical industry.

• Strong knowledge of GMP, FDA regulations, and industry standards.

• Ability to work effectively in a team-oriented environment.

• Excellent documentation and communication skills.

• Willingness to work fully onsite in Pennington, NJ.