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BRBristol Myers Squibb

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

Boudry
Full-timeOn-siteSenior

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.

Requirements

  • 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

Tasks

  • 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

Work Experience

  • 3 - 5 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • FrenchNative
  • EnglishBusiness Fluent

Tools & Technologies

  • SAP
  • MES
  • HMI

Benefits

Flexible Working

  • Balance and flexibility in work environment

Corporate Discounts

  • Competitive benefits, services and programs

Mentorship & Coaching

  • Resources for personal and professional goals

Other Benefits

  • Support for people with disabilities
  • Reasonable workplace accommodations/adjustments
  • Fraud protection information
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bristol Myers Squibb and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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