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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
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