Sanofi · 3 hours ago
Validation Engineer (contract)
Swiftwater, PA
Contract
Onsite
Senior Level
$75/hr - $98/hr
6+ years expSanofi is a pharmaceutical company seeking an experienced Validation Engineer to support computerized system validation activities within a GMP-regulated manufacturing environment. The role focuses on the validation of MES and ERP systems, ensuring compliance with regulatory and quality standards.
BiotechnologyHealthcarePharmaceuticalLife ScienceHealth CareTherapeutics
Responsibilities
Lead and execute Computerized System Validation (CSV) lifecycle activities for MES, ERP, and related systems
Develop and review validation documentation including URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports
Support computerized equipment qualification efforts
Ensure compliance with GMP, Quality System Regulations (QSR), and 21 CFR Part 11
Lead and support CAPA (Corrective and Preventive Action) investigations and remediation activities
Partner cross-functionally with Quality, Manufacturing, IT, and Engineering teams
Manage multiple validation projects while meeting strict deadlines
Maintain accurate and audit-ready documentation
Qualification
Required
Bachelor's degree in Engineering or related technical discipline required
6–9 years of experience in pharmaceutical, biopharmaceutical, or regulated manufacturing environment
Demonstrated experience validating MES and/or ERP systems
Strong understanding of validation lifecycle principles and regulatory compliance requirements
Experience leading or supporting CAPA activities
Detail-oriented with strong organizational skills
Ability to manage multiple projects concurrently
Strong written and verbal communication skills
Preferred
Master's degree
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.98BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.72B
2025-03-05Post Ipo Debt· $1.62B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-02-12
Investing.com
2026-02-12
Company data provided by crunchbase