A Black Diamond client has a large facility with ongoing operations for API Manufacturing and need additional support for Qualification, Maintenance, commissioning, and other facility projects. They are looking for a Senior Level Validation Engineer who is a SME in API manufacturing, knowledge across all things Validation/QA who can support work from Equipment, Metrology, CSV and auditing of the labs and inspection of that. They will be mostly working in a commercial QC lab and R&D lab.
Skills & Qualifications
- Minimum of 10 years of pharmaceutical experience or related (fine chemicals), preferably with a plant manufacturing focus.
- GMP and technical writing experience with protocol and report preparation.
- Experience with quality systems, lab equipment qualification and analytical method transfer preferred.
- Knowledge of QC analytical techniques is required (for example, HPLC, GC, KF, IR, optical rotation, etc.), Empower 3 experience is preferred.
- Working knowledge of and/or implementation/validation experience with Empower, as well as knowledge of LIMS and CSV.
- Project management or supervisory experience preferred.
- Knowledge of 21 CFR 110, 21 CFR 211, ICH Q7, Q9 and Q10 and other regulatory standards governing the manufacture of bulk drug substance.
- Tech transfer experience is a plus
SME Validation Engineer (276639)