Spray Drying Process Engineer

Spray Drying Process Engineer

Couvet Vollzeit Kein Homeoffice möglich
WuXi AppTec
STA Pharmaceutical Switzerland is part of WuXi AppTec. The site is located in Couvet, canton Neuchatel.
We are expanding our capabilities and building a brand new Spray Drying facility, and our first Spray Dryer has just been delivered.
Job Overview Working closely with a cross‑functional team, the Spray Drying Process Engineer will transfer new Spray Drying processes, including reviewing equipment, batch records and parameters. The Engineer will work closely with Production Operators & Technicians to ensure manufacturing processes comply with GMP/cGMP regulations and safety standards. As the point of contact for troubleshooting, you will effectively resolve technical issues, including managing deviations, CAPAs and change controls.
Essential Job Functions
Tech transfer: review equipment, batch records and parameters for new processes
Accurately author / revise production GMP documentation and ensure timely approval
Train new employees and act as a training reference (On the Job Qualified Trainer) for new processes
Work closely with Production Operators & Technicians to configure and adjust equipment and process parameters (temperatures, flow rates, pressure, atomization speed, etc.) to ensure compliant product
Lead troubleshooting of process near misses & failures, including deviations, CAPAs and change controls
Ensure the production of batches in a GMP environment and work independently and efficiently according to the manager’s instructions
Participate in and support the qualification of equipment and the validation of processes
Generate maintenance requests in the event of equipment failure and follow up until production resumes
Comply with the guidelines and instructions defined in the quality system
Comply with the safety and security rules. When required, perform risk assessments and ensure identified hazards are resolved and any residual risk is acceptable
Report dangerous situations, near misses/incidents, and accidents that may occur on site to your direct manager and the EHS department
Experience / Education
5+ years' pharmaceutical spray drying experience
Master’s in life science, preference Chemical Engineering
Knowledge / Skills / Abilities
Thorough knowledge of GMP
Fluent in English. French is advantageous
Organized and rigorous, with strong interpersonal skills for teamwork
Clear communication with support departments
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin or protected veteran status and will not be discriminated against on the basis of disability.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
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WuXi AppTec

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