CQV Engineers (Multiple Levels)

About the Role

PSC Biotech is seeking CQV and Validation Engineers at multiple experience levels to support pharmaceutical and biotechnology manufacturing projects. These roles are crucial for commissioning, qualification, and validation efforts across various project types within regulated GMP environments. Responsibilities will be scaled based on experience and technical expertise, with opportunities available for entry-level through senior-level professionals.

Key Responsibilities

• Validation Execution & Documentation

• Author, review, execute, and close commissioning, qualification, and validation protocols and reports.

• Support installation, operational, and performance verification activities for facilities, utilities, equipment, and manufacturing systems.

• Execute field testing and document results according to established quality and documentation standards.

• Assist with protocol revisions, data analysis, and final report generation.

• Maintain traceability between requirements, risk assessments, testing activities, and validation deliverables.

• Project Support

• Coordinate with project engineers, manufacturing personnel, quality representatives, automation engineers, and vendors during project execution.

• Support project schedules, execution plans, and commissioning readiness activities.

• Participate in project meetings and provide status updates on assigned deliverables.

• Assist with turnover, startup, and operational readiness activities.

• Quality & Compliance

• Follow approved procedures, validation strategies, standard operating procedures, and Good Documentation Practices (GDP).

• Support investigations, deviations, discrepancies, and corrective action activities.

• Ensure documentation is completed accurately and in a timely manner.

• Contribute to inspection readiness and audit support activities.

Requirements & Tech Stack

• All Levels
• Bachelor's degree in Engineering, Biotechnology, Biology, Chemistry, Pharmaceutical Sciences, or a related technical discipline.
• Experience within biopharmaceutical, cell culture, biologics, vaccine, or sterile manufacturing facilities.
• Experience with the digital validation platforms Kneat Gx required.
• Experience supporting one or more of the following:
• Commissioning
• Facility Qualification
• Utility Qualification
• Equipment Qualification
• Cleaning Validation
• Sterilization Validation
• Computerized Systems Validation (CSV)
• Temperature Mapping
• Automation Validation
• Experience with manufacturing execution systems (MES), SCADA, PLC-controlled systems, data integrity programs, or other GMP automation platforms.
• Ability to work in a hybrid environment with onsite support during commissioning, startup, and peak execution periods.