Senior Process Engineer Associate Director Principal Process Engineer

Responsible for ensuringprocess includes implementprojects and improvement initiatives as the technical formaintaininga strong relationship with thePET.

Major Responsibilities:

• Serve as the Process/Product SME for OSD manufacturing owning process stewardshipcenterlinesPFMEASstandard 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 methodsand working with OE Lean as needed to co-lead kaizens andproblem solvingefforts.

• 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 SOPsPAS-Xrecipesand 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 andmaintainprocess knowledge lessons learned and best practices.

• Own product Bills of Materials and support raw materials control including new material introductionflavormanagement and collaboration with QA and Procurement on material risk assessments.

• Partner with Engineering on capital projects as area SME;identifyand 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-XTrakSys data historians HMI) and automation interfaces toanalyze 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

MinimumRequirements:

• BS in Engineeringpharmacyor related scientific discipline
• Minimum5years experiencein GMP or regulated production environment

• Proficiencyin at least one of the following disciplines: equipment process/materials maintenance project delivery

• Solid organization problemsolvinganddecision-making

• Solidteamworkand communication skills (oral and written)

• Working knowledge of Microsoft Office Suite (Word Excel Project)

• Minimum3years experiencein GMP or regulated production environment

• Demonstrated ability to simultaneously manage multipleprojects

• Experience in LEAN Six Sigma / Green Belt /ability to apply DMAIC SPC RCA andanalytical 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 technicalrelationships.

• Strong mechanical/technical aptitude

• Experienced in working in a LEAN manufacturingenvironment

• LEANSix Sigma Black Belt

• Working knowledge of SAPTrakSys PAS-X Veeva/EQV Quality Systems

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.