In collaboration with the SDP Area CQV Lead, prepare and execute commissioning and validation testing for equipment and utilities at the Cruiserath Drug Product Facility, in alignment with site and global BMS procedures.
Responsibilities
- Develop and execute CQV testing documentation for benchtop, mobile, analytical, PAT, incubators, BSCs, and TCU equipment in the Sterile Drug Product facility.
- Ensure key project deliverables are met for safety, CQV schedule, and quality of project-related documentation/electronic records for assigned equipment and utilities.
- Verify that GMP equipment is tested in compliance with Good Manufacturing Practices, company policies, and EU & FDA regulations.
- Ensure all equipment is tested according to project-related commissioning standards.
- Manage deviations associated with assigned equipment and utilities.
- Conduct risk management by identifying and categorizing CQV risks, and develop action plans to mitigate qualification risks.
- Execute FAT testing and integrate results into the overall qualification process for assigned equipment, facilities, and utilities.
- Complete all assigned training on time to meet site metrics.
Required Competencies
- Proven ability to execute CQV testing from initiation through completion.
- Experience managing CQV projects through the full lifecycle, from design to C&Q and handover.
- Strong track record of working as part of a diverse team of CQV professionals/contractors, delivering tasks safely, on time, with a focus on quality.
- Experience in CQV of Drug Substance/Drug Product small equipment with integrated automation.
- Solid background in document preparation, execution, and task planning for CQV projects, with demonstrated on-time performance.
- Excellent communication skills and the ability to influence others effectively.
- Experience working in teams in a matrix environment to deliver CQV elements.
- Familiarity with electronic validation platforms (e.g., ValGenesis, Kneat).
Required Qualifications and Desired Experience
- Minimum of a BS degree in a scientific, technical, or engineering discipline.
- 3-5 years of pharmaceutical industry experience, ideally with exposure to sterile Drug Product filling lines.
