Validation Engineer - North Carolina
Validation Engineer (CSV Lead)
Location: Durham, North Carolina
Provide computer system validation support for a leading contract development and manufacturing organization (CDMO) specializing in the production of biologics and advanced therapies. You will be responsible for the validation strategy and SDLC documentation for Werum PAS-X MES and Fill/Finish systems, encompassing PLCs, SCADA, MES, and Serialization, within the life sciences manufacturing environment.
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.
- Ensure compliance with data integrity requirements and implement measures to maintain data integrity throughout the validation lifecycle.
- Support and provide guidance to the project team regarding CSV (Computer Systems Validation) principles and best practices.
- Liaise with external vendors and contractors to coordinate validation activities and ensure adherence to project timelines.
Skills and Experience
- Bachelor's degree in Engineering, Computer Science, or a related field.
- 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.
- Excellent problem-solving skills and the ability to analyze complex systems and processes.
- Ability to collaborate effectively with cross-functional teams.
- Proactive mindset with a strong attention to detail and the ability to prioritize tasks effectively.
- Experience working in a regulated GxP environment.
- Previous experience in a leadership or mentoring role is highly desirable.
Joining Valspec as a Validation Engineer (CSV) will provide you with an opportunity to make a significant impact in the validation and CSV processes for cutting-edge life sciences manufacturing systems. If you are a highly motivated and detail-oriented professional with a passion for ensuring compliance and data integrity, we encourage you to apply.
Benefits included.
Why Join Valspec?
At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:
- Premium medical coverage
- 401(k) with company match
- Tuition reimbursement
- Unique performance incentives
- And more — all designed to support your growth, well-being, and future.
Join a team where your contributions matter, your development is prioritized, and your success is shared.