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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Commissioning, Qualification, and Validation processes within the pharmaceutical sector, including the preparation and execution of validation protocols and risk assessments. Proficient in regulatory compliance with GxP, GDP, GMP, and 21 CFR Part 11.
Highest-signal resume keywords
Master's Degree In EngineeringPharmaceutical Regulatory RequirementsV-Model ProficiencyValidation Protocols ExecutionAnalytical Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
CommissioningQualificationValidationRisk AssessmentsFAT/SAT ProtocolsIQ, OQ, PQ ProtocolsValidation Master Plan PreparationNon-Conformity TrackingEquipment AssessmentValidation Reporting
Soft Skills
Attention To DetailInterpersonal Skills
Industry Keywords
Pharmaceutical IndustryGxPGDPGMP21 CFR Part 11
About the role
Key responsibilities & impact- Participate in the design review of systems
- Review suppliers’ FAT protocols for systems and verify their consistency with the conclusions of the functional analysis
- Complete supplier SATs
- Receive and commission equipment (FAT/SAT)
- Participate in the preparation of risk assessments and criticality analyses
- Prepare the Validation Master Plan and define the methodology and strategy to be implemented
- Draft and execute IQ, OQ and PQ protocols
- Track non-conformities and associated corrective actions
- Prepare qualification reports
- Assess the need for specific equipment for C&Q testing
- Train testers on test protocols
- Plan and coordinate testers and support-function interventions
- Prepare the Validation Master Plan
- Draft and execute validation protocols in collaboration with Production
- Prepare validation reports
- Work in the pharmaceutical sector as part of the Life Sciences Commissioning, Qualification & Validation team
Requirements
What you’ll need- Master’s degree in General Engineering, Process Engineering, or Production/Utilities Engineering
- At least 5 years of experience with equipment
- Knowledge of the pharmaceutical industry is highly desirable
- Strong knowledge of pharmaceutical regulatory requirements, including GxP, GDP, GMP and 21 CFR Part 11
- Proficiency in the V-Model is essential for this position
- Technical English proficiency is an advantage
- Strong analytical skills, attention to detail and excellent interpersonal skills
- Occasional travel is required, particularly to suppliers in France and internationally
- Geographical mobility within France may be required
Benefits
Comp & perks- Company teleworking policy
- Employee benefits committee (holiday vouchers, cultural benefits, sports subsidies, etc.)
- 13 additional days off (RTT) plus a time savings account
- Meal voucher card
- Health and disability insurance
- Holiday bonus
- Employee referral bonus
- Contribution toward the cost of public transportation passes or a sustainable mobility allowance