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.
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
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.
Qualifications
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.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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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.
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
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.
Qualifications
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.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr
