valspec
Validation Engineer - North Carolina
At a Glance
- Location
- Non-Headquarters
- Experience
- 5+ years
- Posted
- 2026-07-28T15:40:08-04:00
Key Requirements
Required Skills
Domain Knowledge
- Engineering
- Manufacturing
- Medical
- Pharmaceutical
- Regulatory
Benefits & Perks
including: Premium medical coverage 401(k) with company match Tuition reimb
Requirements
Minimum of 5 years of experience in CSV and validation within the pharmaceutical or biopharmaceutical industry.
Strong expertise in validating MES and Fill/Finish systems, including experience with PLCs, SCADA, MES, and Serialization.
In-depth knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards (GAMP, 21 CFR Part 11) related to CSV and validation.
Proven experience in developing and executing validation strategies, plans, protocols, and reports.
Solid understanding of SDLC (Software Development Life Cycle) and familiarity with Agile methodologies.
Extensive experience with data integrity principles and implementation in CSV activities.
Responsibilities
Develop and execute validation strategies and plans for Werum PAS-X and PLC-based Fill/Finish systems in compliance with regulatory requirements, industry best practices, and company standards.
Systems may include Werum PAS-X, Siemens and Allen-Bradley PLCs, and Aveva Wonderware SCADA.
Lead the creation, review, and approval of validation deliverables, including validation plans, protocols, reports, risk assessments, and traceability matrices.
Collaborate with cross-functional teams to ensure appropriate requirements gathering and mapping for validation activities.
Conduct and oversee FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and commissioning activities for BAS and Fill/Finish systems.
Perform risk assessments and impact analyses to identify potential issues and develop mitigation plans.