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.
Duties / Responsibilities 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.
Participate in commissioning, FAT/SAT, IOQ, PQ, and operational readiness for new equipment.
Provide expertise in the use of process automation systems (SAP, MES, HMI).
Write system requirement definitions and 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 requirements and support MES recipe/PRC/UAT creation as process unit SME.
Lead data integrity risk assessment.
Prepare and assist operations teams with new equipment set up and troubleshooting.
Manage vendor communication related to manufacturing requests.
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 orders and review/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 and lead local continuous improvement initiatives.
Provide technical expertise for investigations, CAPAs, and process improvement upon request.
Participate in audits and inspections.
Ensure on‑time closure of quality records (e.g., CAPA, action plan, document periodic review).
Own and lead change control at the discretion of the production team.
Qualifications Bachelor’s degree in Engineering or Life Sciences.
3–5 years in technical operations within a 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.
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