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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in equipment qualification and validation processes within the pharmaceutical industry, including writing and executing IQ, OQ, and PQ protocols, and preparing comprehensive qualification and validation reports. Proficient in regulatory requirements such as GxP, GDP, GMP, and 21 CFR Part 11, with strong analytical and interpersonal skills.
Highest-signal resume keywords
Master's Degree In EngineeringEquipment QualificationPharmaceutical Regulatory RequirementsV-Model KnowledgeAnalytical Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
IQ ProtocolsOQ ProtocolsPQ ProtocolsValidation ProtocolsRisk AssessmentsCriticality AnalysesQualification ReportsNonconformity TrackingFAT/SAT CommissioningMaster Qualification Plan
Soft Skills
Analytical SkillsInterpersonal SkillsRigorTraining 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 and verify their consistency with the functional analysis
- Complete supplier SATs
- Receive and commission equipment (FAT/SAT)
- Participate in the preparation of risk assessments and criticality analyses
- Prepare the master qualification plan
- Write and execute IQ, OQ, and PQ protocols
- Track nonconformities and associated corrective actions
- Prepare qualification reports
- Assess the need for specific equipment for C&Q testing
- Train testers on the protocols
- Plan and coordinate testers and support-services interventions
- Prepare the master validation plan
- Write and execute validation protocols with the production team
- Prepare validation reports
Requirements
What you’ll need- Master’s degree in General Engineering, Process Engineering, Production Engineering, or Utilities Engineering
- At least 5 years of experience with equipment
- Knowledge of the pharmaceutical industry is highly desirable
- Proficiency in pharmaceutical regulatory requirements: GxP, GDP, GMP, and 21 CFR Part 11
- Extensive knowledge of the V-model is required
- Technical proficiency in English is a plus
- Strong analytical skills, rigor, and excellent interpersonal skills
- Occasional travel to suppliers in France or internationally
- Geographical mobility within France may be required
Benefits
Comp & perks- Internal remote-working policy
- Works Council benefits (holiday vouchers, cultural activities, sports subsidies, etc.)
- 13 additional leave days (RTT) plus a time savings account
- Meal voucher card
- Health and disability insurance
- Holiday bonus
- Employee referral bonus
- Contribution toward public transportation passes or sustainable mobility allowance