Senior Process Engineer / Associate Director Principal Process Engineer

Responsible for ensuring process improvement within the PET. This includes equipment, materials, and procedures. Leads and implement projects and improvement initiatives as the technical expert. Responsible for maintaining a strong relationship with the PET.

Major Responsibilities :

• Serve as the Process/Product SME for OSD manufacturing, owning process stewardship, centerlines, PFMEAS, standard work, and control strategies to meet safety, quality, and throughput targets.
• Lead change control and risk management for product, equipment, and process changes, ensuring scientific justification, patient/product safety, and regulatory compliance.
• Provide on-the-floor technical support for batch execution; lead troubleshooting, deviation investigations, and development/implementation of effective CAPAs.
• Define calculation logic and SPC strategy for process KPIs (OEE drivers, yield, scrap, cycle times); ensure data accuracy and signal detection in tier routines.
• Drive continuous improvement and operational excellence to improve yield, throughput, OEE, and quality; execute small improvement projects and cost reduction initiatives, leveraging SPC, Six Sigma, SMED, and analytical troubleshooting methods and working with OE Lean as needed to co-lead kaizens and problem solving efforts.
• Author/own PPQ strategy and execution; lead Continued Process Verification (CPV) plans and periodic product reviews; set readiness criteria for transfer and validation.
• Author and review GMP documentation (MBRs, BOMs, SOPs, PAS-X recipes and parameters, etc.), ensuring ALCOA+ and data integrity requirements.
• Serve as process owner and technical subject matter expert in internal/external audits and inspections.
• Define and maintain CPPs and CQAs across OSD unit operations (weigh/dispense/blend, wet/spray granulation, milling, compression, film coating); support process and cleaning validation, scale-up, and tech transfer.
• Train operators and technical staff on OSD processes and troubleshooting; capture and maintain process knowledge, lessons learned, and best practices.
• Own product Bills of Materials and support raw materials control, including new material introduction, flavor management, and collaboration with QA and Procurement on material risk assessments.
• Partner with Engineering on capital projects as area SME; identify and prioritize opportunities feeding the formulation Capital Plan; ensure installed solutions meet company standards and regulatory/SHE requirements.
• Collaborate within the PET and broader Engineering community and with external equipment/material suppliers to sustain equipment reliability and drive technology improvements.

• Utilize manufacturing/data systems (e.g., PAS-X, TrakSys, data historians, HMI) and automation interfaces to analyze process performance and enable data-driven decisions.
• May require coverage during off-shifts or weekends to support launches, shutdowns, training, CPV, and critical operations as business needs dictate

Minimum Requirements:

• BS in Engineering, pharmacy or related scientific discipline
• Minimum 5 years’ experience in GMP or regulated production environment
• Proficiency in at least one of the following disciplines: equipment, process/materials, maintenance, project delivery
• Solid organization, problem solving and decision-making
• Solid teamwork and communication skills (oral and written)
• Working knowledge of Microsoft Office Suite (Word, Excel, Project)
• Minimum 3 years’ experience in GMP or regulated production environment
• Demonstrated ability to simultaneously manage multiple projects
• Experience in LEAN Six Sigma / Green Belt / ability to apply DMAIC, SPC, RCA and analytical trouble shooting skills

Preferred Qualifications:

• Experience in any of: Process Development and Optimization, Scale up and Tech Transfer, GMP Regulation, Process & Cleaning Validation, Controls and Automation
• Ability to generate and interpret technical documents
• Experienced in managing external technical relationships.
• Strong mechanical/technical aptitude
• Experienced in working in a LEAN manufacturing environment
• LEAN Six Sigma Black Belt
• Working knowledge of SAP, TrakSys, PAS-X, Veeva/EQV Quality Systems