BIOPHARMACEUTICAL – C&Q Manager
On-site · Toluca, México, Mexico
Job Summary
Biopharmaceutical – C&Q Manager to lead commissioning, qualification and start-up activities for upstream/downstream bioprocess systems and related equipment in pharma/biotech facilities. Responsibilities include leading qualification deliverables across the project lifecycle (DQ, FAT, SAT, IQ/OQ/PQ, RTMs, risk assessments), preparing/executing protocols, coordinating cross-functional teams, ensuring adherence to cGMP and SOPs, and maintaining client relationships. Requires senior leadership to guide intermediate and junior engineers, travel to client sites, and ability to manage multiple projects in a fast-paced environment. TN visa sponsorship is offered for work in the US; strong command of English is required; background in bioprocess equipment (fermentation, bioreactors, chromatography, TFF, UF), validation strategies (URSs, CPPs, VPPs, FATs/SATs; IOQs; NCRs; final reports) and experience with process control systems/automation are assets.
Required Qualifications
- Previous Pharmaceutical/Biotech experience is mandatory
- 8+ years in commissioning/validation/qualification in pharma/biotech
- English required (written and spoken)
- Science degree or related discipline (Mechanical, Electrical, Chemical, Biochemical, Electromechanical) along with industry experience
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