Process Safety Engineer
Air Products
Senior Process Engineer, MS&T
Harrow
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Lead technology transfer of branded ophthalmic products to cGMP Contract Manufacturing Organizations (CMOs).
- Serve as the primary point of contact with CMOs and external partners for all technology transfer activities.
- Prepare, review, and approve technical documentation—including protocols, reports, and product/process validation packages (IQ, OQ, PQ)—to ensure accuracy and completeness.
- Provide technical leadership in CMO project transfer meetings, offering guidance and managing deliverables.
- Collaborate cross-functionally with MS&T, Quality Assurance, Quality Control, Supply Chain, and other departments to ensure seamless transfer and maintenance of processes at CMOs.
- Compile and analyze process data, communicate project status, identify trends, and meet internal and external reporting requirements.
- Support CMO selection by assessing manufacturing capabilities and driving initiatives to reduce and improve process variability.
- Troubleshoot and resolve manufacturing challenges by identifying root causes and implementing effective corrective actions.
- Provide process engineering recommendations to ensure transferred products are robust, compliant, and aligned with current manufacturing technologies.
- Partner with manufacturing teams to ensure compliance and product quality throughout the entire engineering and commercial operations process.
- Oversee product transitions into CMOs, ensuring readiness for production, quality assurance, and regulatory compliance.
- Serve as Subject Matter Expert (SME) for critical processes and provide technical leadership across the organization.
Requirements
- Bachelor's degree in pharmacy, chemistry, or pharmaceutical engineering with at least six years' pertinent and progressive experience or Master's degree with minimum of three years' experience.
- Experience in Formulations, Process Development or Technical Services, with direct experience in formulation and process development of Sterile Products.
- Strong understanding of aseptic manufacturing, aseptic filling and sterilization required.
Benefits
- Minimal travel to CMOs might be necessary.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
technology transfertechnical documentationprocess validationprocess engineeringformulation developmentaseptic manufacturingsterile productsroot cause analysiscorrective actionsdata analysis
Soft skills
technical leadershipcollaborationcommunicationguidanceproblem-solvingproject managementcross-functional teamworkanalytical thinkingattention to detailstakeholder management
