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BRBristol Myers Squibb

Senior Specialist - Technical Process Excellence, Commercial Operations(m/w/x)

Boudry
VollzeitVor OrtSenior

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

  • Französischfließend
  • Englischverhandlungssicher

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
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Bristol Myers Squibb erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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