Senior Specialist - Technical Process Excellence, Commercial Operations

Senior Specialist – Technical Process Excellence, Commercial Operations

Fixed Term

Contract:

1 year

Provides advanced technical leadership to ensure robust, compliant, and efficient manufacturing processes. The role owns complex technical documentation, supports equipment lifecycle activities, and acts as a subject‑matter expert for manufacturing process, MES, and data integrity. Through hands‑on floor expertise, cross‑functional collaboration, and leadership of continuous improvement and problem‑solving initiatives, the Senior Specialist supports operational excellence, quality event execution, and change management across commercial manufacturing operations.

• Provide Expertise in manufacturing processes
• Review and approve protocol for technical batches
• Bring floor expertise during risk assessments.
• Write rework/repackaging protocols
• Write and own technical documentation
• Participating in the Commissioning, FAT/SAT, IOQ, PQ and Operational Readiness as part of new equipment
• Provide Expertise in the use of process automation system SAP, MES, Equipment Human/Machine Interface (HMI)
• Write System requirement definition & associated supporting quality records and documentation (e.g. change management) to support equipment enhancement post product commercialization or Manufacturing process
• Contribute to MES Functional system requirement and Support MES recipe/PRC/UAT creation as Process unit SME
• Lead to Data Integrity risk assessment
• Prepare and assist Operations teams with new equipment set up and troubleshooting
• Vendor management related to manufacturing request
• Review equipment qualification documentation
• Act as business owner in system periodic review and approval
• Use Capex process for capital funding
• Act as primary point of contact for Manufacturing purchase Order
• Write, Review and approve LO/TO documentation (e.g. ECP)
• Participate in process troubleshooting and performance improvement projects.
• Lead A3 problem solving initiatives related to technical topics
• Own & lead local continuous improvement initiatives.
• Provides technical expertise for investigation, CAPAs, Process improvement and in other various topics upon request
• Participate in audits and inspections
• Ensure on-time closure of quality records (e.g. CAPA, Action, document periodic review,..)
• Own and lead change control at the discretion of the production team
• This job description is not intended to be exhaustive; additional duties and responsibilities may be assigned as needed to meet business 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 a related technical field.
• Significant experience in regulated pharmaceutical manufacturing environments.
• Strong expertise in manufacturing processes, equipment lifecycle, and qualification activities (FAT/SAT, IOQ, PQ).
• Proven experience with SAP, MES, HMI, and process automation systems in a GMP context.
• Solid background in technical and quality documentation, change control, CAPAs, investigations, and data integrity.
• Demonstrated ability to lead continuous improvement initiatives and structured problem solving (e.g., A3).
• Strong collaboration, communication, and technical leadership skills, with audit and inspection experience.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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