Process Engineering Lead - Formulation, Filling, Inspection (CVRM)

Pharma Technical Manufacturing (PTM) is seeking a Process Engineering Lead to oversee process design, qualification, startup, and registration at a new manufacturing site in Holly Springs, North Carolina. The role involves providing scientific and technical leadership, partnering with various teams, and driving optimal facility and operations design. The ideal candidate will have experience in pharmaceutical industry technology, process validation, and regulatory submissions.

Requirements

• Bachelor's, Master's, or Ph.D. degree in bio/chemical engineering or similar
• 11+ years of experience in technology of pharmaceutical industry
• Expertise in drug product manufacturing relevant unit operations (Compounding, Filling, Inspection)
• Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections
• Advanced project management skills
• Strong organizational and interpersonal skills
• Up-to-date knowledge of cGMP's, Health Authority regulations, and Quality Systems

Benefits

• Relocation benefits
• Discretionary annual bonus may be available