ph3Senior Specialist - Technical Process Excellence, Commercial Operations /h3pFixed Term Contract: 1 year /ppProvides 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. /ph3Duties / Responsibilities /h3ulliProvide expertise in manufacturing processes. /liliReview and approve protocol for technical batches. /liliBring floor expertise during risk assessments. /liliWrite rework/repackaging protocols. /liliWrite and own technical documentation. /liliParticipate in commissioning, FAT/SAT, IOQ, PQ, and operational readiness for new equipment. /liliProvide expertise in the use of process automation systems (SAP, MES, HMI). /liliWrite system requirement definitions and associated supporting quality records and documentation (e.g., change management) to support equipment enhancement post product commercialization or manufacturing process. /liliContribute to MES functional system requirements and support MES recipe/PRC/UAT creation as process unit SME. /liliLead data integrity risk assessment. /liliPrepare and assist operations teams with new equipment set up and troubleshooting. /liliManage vendor communication related to manufacturing requests. /liliReview equipment qualification documentation. /liliAct as business owner in system periodic review and approval. /liliUse Capex process for capital funding. /liliAct as primary point of contact for manufacturing purchase orders and review/approve LO/TO documentation (e.g., ECP). /liliParticipate in process troubleshooting and performance improvement projects. /liliLead A3 problem‑solving initiatives related to technical topics. /liliOwn and lead local continuous improvement initiatives. /liliProvide technical expertise for investigations, CAPAs, and process improvement upon request. /liliParticipate in audits and inspections. /liliEnsure on‑time closure of quality records (e.g., CAPA, action plan, document periodic review). /liliOwn and lead change control at the discretion of the production team. /li /ulh3Qualifications /h3ulliBachelor’s degree in Engineering or Life Sciences. /lili3–5 years in technical operations within a GMP environment. /liliKnowledge of validation and technical documentation. /liliProficiency in French (mandatory) and English. /liliAdvanced degree in Engineering, OSD Pharmaceutical Sciences, or a related technical field. /liliSignificant experience in regulated pharmaceutical manufacturing environments. /liliStrong expertise in manufacturing processes, equipment lifecycle, and qualification activities (FAT/SAT, IOQ, PQ). /liliProven experience with SAP, MES, HMI, and process automation systems in a GMP context. /liliSolid background in technical and quality documentation, change control, CAPAs, investigations, and data integrity. /liliDemonstrated ability to lead continuous improvement initiatives and structured problem‑solving (e.g., A3). /liliStrong collaboration, communication, and technical leadership skills, with audit and inspection experience. /li /ulpVisit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. /p /p #J-18808-Ljbffr
