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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in validation engineering and compliance within the biopharmaceutical industry, with a strong focus on risk-based verification approaches and hands-on experience in bioprocessing equipment qualification. Proven ability to lead technical investigations and ensure alignment of critical process parameters with quality attributes.
Highest-signal resume keywords
CQV Engineering ExperienceRisk-Based Verification ApproachesBioprocessing Equipment QualificationRoot-Cause TroubleshootingThermal Validation Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation Master PlansUser Requirement SpecificationsDesign QualificationFactory Acceptance TestingSite Acceptance TestingInstallation QualificationOperational QualificationPerformance QualificationBioreactor QualificationEnvironmental Tracking
Soft Skills
LeadershipProblem-SolvingCommunication
Tools & Technologies
Thermal Mapping SoftwareEnvironmental Monitoring SystemsCleanroom Classification ToolsCIP/SIP SystemsSingle-Use Technologies
Industry Keywords
BiopharmaceuticalBiotechnologyPharmaceutical IndustryEU GMPFDA 21 CFR Part 211ISPE Baseline GuideWFIPWClean SteamMicrobial Systems
Tech Stack
Tools & technologiesAirflow
About the role
Key responsibilities & impact- Author, review, and execute validation deliverables including VMPs, URS, DQ, FAT/SAT, IQ/OQ/PQ
- Apply ISPE risk-based verification approaches in compliance with EU GMP Annex 1 and 15 and FDA 21 CFR Part 211
- Serve as the on-site technical Subject Matter Expert during internal quality audits and external regulatory inspections
- Lead qualification and validation of upstream and downstream bioprocessing equipment, facility systems, and CIP/SIP cycles
- Ensure alignment between critical process parameters and critical quality attributes
- Oversee CQV and monitoring for WFI, PW, Clean Steam, and Process Gases
- Lead technical root-cause investigations for bioburden, microbial-limit, and TOC-spike excursions
- Direct cleanroom classification and airflow smoke studies
- Manage thermal mapping for cold rooms, freezers, incubators, and warehouses under static and loaded conditions
- Support capital projects, operational changes, and regulatory inspections across manufacturing sites
Requirements
What you’ll need- Bachelor’s degree in engineering, life sciences, or a related technical discipline
- 8+ years of direct CQV or validation engineering experience within the biopharmaceutical, biotechnology, or pharmaceutical industry
- Strong command of risk-based verification approaches such as ISPE Baseline Guide volume 5
- Hands-on qualification experience with bioreactors, fermenters, single-use technologies, and autoclaves
- Demonstrated success in scaling and troubleshooting cell culture or microbial systems
- Proven diagnostic and root-cause troubleshooting capability resolving bioburden excursions and TOC spikes in WFI/PW distribution networks
- Proficiency in environmental tracking and thermal validation hardware/software platforms
- Ability and willingness to travel 0–30% to support various manufacturing sites and vendor locations
Benefits
Comp & perks- Diverse and inclusive work environment
- Opportunities to acquire new skills and experiences
- Travel support for various manufacturing sites and vendor locations