Validation Engineer - North Carolina

Valspec; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

ESOP

Premium medical coverage

401(k) with company match

Job summary

Valspec is seeking a flexible Validation Engineer (CSV Lead) to drive validation strategy and SDLC documentation for Werum PAS-X MES and Fill/Finish systems in a North Carolina manufacturing setting. The role requires leadership and 5+ years in CSV within the pharmaceutical sector, with extensive experience validating MES, PLCs, SCADA, serialization, and compliance with FDA/EMA and 21 CFR Part 11.

Join a team focused on data integrity, validation deliverables, and collaboration with vendors to

Qualifications

• Bachelor's degree in engineering or computer science.
• Minimum of 5 years in CSV/validation within pharma/biopharma.
• Experience validating MES/Fill/Finish systems with PLCs, SCADA, MES, and Serialization.
• Strong knowledge of FDA/EMA regulations and 21 CFR Part 11.

Responsibilities

• Develop validation strategies and plans for Werum PAS-X and PLC-based Fill/Finish systems.
• Lead creation, review, and approval of validation deliverables and traceability matrices.
• Oversee FAT/SAT and commissioning activities for BAS and Fill/Finish systems.
• Collaborate with cross-functional teams for requirements gathering.
• Maintain data integrity across the validation lifecycle.
• Mentor and guide project teams on CSV principles.

Skills

CSV Lead

Validation

Regulatory knowledge

SDLC

Agile

Data integrity

Leadership

Education

Bachelor's degree in Engineering/CS

Tools

Werum PAS-X

Siemens PLC

Allen-Bradley PLC

SCADA

Wonderware

Serialization

Job description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Provide computer system validation support for a leading contract development and manufacturing organization (CDMO) specializing in the production of biologics and advanced therapies. We are seeking a flexible and adaptable Validation Engineer (CSV Lead) to represent our team in North Carolina. In this role, 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
• 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.

Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

The application deadline for this role is August 28, 2026