CQV Cleaning Characterization Lead – GMP Biopharma
Veg Group
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Job summary
Validation & Engineering Group, Inc. seeks a CQV Technical Lead – Cleaning Characterization to support a biologics drug substance transfer and GMP expansion at a facility in Juncos, Puerto Rico.
The candidate will lead cleaning characterization and verification activities, develop protocols, evaluate data, and coordinate with Manufacturing, Engineering, Quality, and the client Verification team to ensure timely reporting.
Qualifications
- Bachelor's degree in Engineering, Science, Biotechnology, Microbiology, Chemistry, or related technical discipline.
- Significant CQV or validation experience in pharmaceutical or biotechnology manufacturing.
- Knowledge of CIP systems/circuits, bioprocess equipment, cleaning cycles, and GMP documentation.
- Experience developing and executing cleaning protocols and reports.
- Strong technical writing and investigation skills.
- Ability to lead multidisciplinary teams in a GMP manufacturing environment.
Responsibilities
- Lead cleaning characterization and verification activities for upstream and downstream process systems.
- Develop, review, and support approval of technical documentation including Cleaning Characterization Protocols and acceptance criteria.
- Coordinate execution activities with Manufacturing, Engineering, QC, EHS, Quality, and client Verification team.
- Lead technical triage of unexpected results, discrepancies, or execution issues.
- Support deviation investigations and CAPA activities when required.
Skills
Education
Tools
Job description
Validation & Engineering Group, Inc. seeks a CQV Technical Lead – Cleaning Characterization to support a biologics drug substance transfer and GMP expansion at a facility in Juncos, Puerto Rico.
The candidate will lead cleaning characterization and verification activities, develop protocols, evaluate data, and coordinate with Manufacturing, Engineering, Quality, and the client Verification team to ensure timely reporting.
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