Dein persönlicher KI-Karriere-Agent
Senior Specialist - Technical Process Excellence, Commercial Operations(m/w/x)
Technical leadership for compliant manufacturing processes at a biopharmaceutical company. 3-5 years GMP technical operations experience and French proficiency required. Flexible work environment, resources for personal and professional goals.
Anforderungen
- Bachelor’s degree in Engineering or Life Sciences
- 3–5 years in technical operations within GMP environment
- Knowledge of validation and technical documentation
- Proficiency in French (mandatory) and English
- Advanced degree in Engineering, OSD Pharmaceutical Sciences, or related technical field
- Significant experience in regulated pharmaceutical manufacturing
- Strong expertise in manufacturing processes, equipment lifecycle, and qualification activities
- Proven experience with SAP, MES, HMI, and process automation systems in GMP context
- Solid background in technical and quality documentation, change control, CAPAs, investigations, and data integrity
- Ability to lead continuous improvement and structured problem solving
- Strong collaboration, communication, and technical leadership skills, with audit and inspection experience
- Encouragement to apply even if resume doesn't perfectly align
Aufgaben
- Provide advanced technical leadership
- Ensure robust, compliant manufacturing processes
- Own complex technical documentation
- Support equipment lifecycle activities
- Act as subject-matter expert for manufacturing processes
- Act as subject-matter expert for MES and data integrity
- Conduct risk assessments on the manufacturing floor
- Write rework and repackaging protocols
- Write and own technical documentation
- Participate in new equipment commissioning
- Participate in FAT/SAT, IOQ, PQ, and operational readiness
- Provide expertise in process automation systems (SAP, MES, HMI)
- Write system requirement definitions
- Support quality records and documentation
- Contribute to MES functional system requirements
- Support MES recipe/PRC/UAT creation
- Lead data integrity risk assessments
- Assist operations teams with new equipment setup
- Troubleshoot new equipment issues
- Manage vendors for manufacturing requests
- Review equipment qualification documentation
- Act as business owner for system reviews
- Use Capex process for capital funding
- Manage manufacturing purchase orders
- Write, review, and approve LO/TO documentation
- Participate in process troubleshooting
- Lead performance improvement projects
- Lead A3 problem-solving initiatives
- Own and lead local continuous improvement
- Provide technical expertise for investigations
- Support CAPAs and process improvements
- Participate in audits and inspections
- Ensure timely closure of quality records
- Lead change control initiatives
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Französisch – fließend
- Englisch – verhandlungssicher
Tools & Technologien
- SAP
- MES
- HMI
Benefits
Flexibles Arbeiten
- Balance and flexibility in work environment
Mitarbeiterrabatte
- Competitive benefits, services and programs
Mentoring & Coaching
- Resources for personal and professional goals
Sonstige Vorteile
- Support for people with disabilities
- Reasonable workplace accommodations/adjustments
- Fraud protection information
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Senior Specialist - Technical Process Excellence, Commercial Operations(m/w/x)
Technical leadership for compliant manufacturing processes at a biopharmaceutical company. 3-5 years GMP technical operations experience and French proficiency required. Flexible work environment, resources for personal and professional goals.
Anforderungen
- Bachelor’s degree in Engineering or Life Sciences
- 3–5 years in technical operations within GMP environment
- Knowledge of validation and technical documentation
- Proficiency in French (mandatory) and English
- Advanced degree in Engineering, OSD Pharmaceutical Sciences, or related technical field
- Significant experience in regulated pharmaceutical manufacturing
- Strong expertise in manufacturing processes, equipment lifecycle, and qualification activities
- Proven experience with SAP, MES, HMI, and process automation systems in GMP context
- Solid background in technical and quality documentation, change control, CAPAs, investigations, and data integrity
- Ability to lead continuous improvement and structured problem solving
- Strong collaboration, communication, and technical leadership skills, with audit and inspection experience
- Encouragement to apply even if resume doesn't perfectly align
Aufgaben
- Provide advanced technical leadership
- Ensure robust, compliant manufacturing processes
- Own complex technical documentation
- Support equipment lifecycle activities
- Act as subject-matter expert for manufacturing processes
- Act as subject-matter expert for MES and data integrity
- Conduct risk assessments on the manufacturing floor
- Write rework and repackaging protocols
- Write and own technical documentation
- Participate in new equipment commissioning
- Participate in FAT/SAT, IOQ, PQ, and operational readiness
- Provide expertise in process automation systems (SAP, MES, HMI)
- Write system requirement definitions
- Support quality records and documentation
- Contribute to MES functional system requirements
- Support MES recipe/PRC/UAT creation
- Lead data integrity risk assessments
- Assist operations teams with new equipment setup
- Troubleshoot new equipment issues
- Manage vendors for manufacturing requests
- Review equipment qualification documentation
- Act as business owner for system reviews
- Use Capex process for capital funding
- Manage manufacturing purchase orders
- Write, review, and approve LO/TO documentation
- Participate in process troubleshooting
- Lead performance improvement projects
- Lead A3 problem-solving initiatives
- Own and lead local continuous improvement
- Provide technical expertise for investigations
- Support CAPAs and process improvements
- Participate in audits and inspections
- Ensure timely closure of quality records
- Lead change control initiatives
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Französisch – fließend
- Englisch – verhandlungssicher
Tools & Technologien
- SAP
- MES
- HMI
Benefits
Flexibles Arbeiten
- Balance and flexibility in work environment
Mitarbeiterrabatte
- Competitive benefits, services and programs
Mentoring & Coaching
- Resources for personal and professional goals
Sonstige Vorteile
- Support for people with disabilities
- Reasonable workplace accommodations/adjustments
- Fraud protection information
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Bristol Myers Squibb
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to transforming patients’ lives through science and promotes global participation in clinical trials.
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