Csv Validation Engineer Jobs in Raleigh, NC (NOW HIRING)

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.

Location: Onsite / Hybrid (Pharma Manufacturing Site)
Industry: Pharmaceutical / Biotech Manufacturing
Focus Areas: MES, PI Historian, OT/IT Systems, Networked Manufacturing Applications

We are seeking a Technical Project Manager / Owner's Agent to lead the delivery of manufacturing digital systems within a GMP pharmaceutical production environment. This role is highly technical and hands-on, serving as the bridge between shop floor automation teams, Quality, and Corporate IT to ensure systems are implemented, validated, and released without compromising product quality, data integrity, or regulatory compliance.

The ideal candidate has deep experience in MES, data historians, and OT/IT infrastructure, paired with a strong understanding of CSV and global GMP regulations.

• Act as the Owner's Representative for manufacturing systems projects from design through implementation and validation
• Lead delivery of MES / NYMI-band systems supporting regulated manufacturing operations
• Coordinate IO / OT network design, implementation, testing, and commissioning
• Oversee deployment and lifecycle management of:
  • OSI PI (PI Data Historian)
  • ThinManager and mobile HMI cart environments
  • FactoryTalk AssetCentre
  • Siemens Simatic Logon Server
• Serve as the primary interface between:
  • Automation & Manufacturing teams
  • Quality & Validation groups
  • Corporate IT and cybersecurity teams
  • External system integrators and vendors
• Ensure all systems are delivered in accordance with GMP, CSV, and Data Integrity requirements
• Manage scope, schedule, risks, and cross-functional dependencies in a regulated environment

• Manufacturing Execution Systems (MES):
  Hands-on project experience with Werum PAS‑X, Siemens Opcenter, or equivalent platforms
• Data Historians:
  Strong experience with OSI PI (PI System) for real-time data capture, reporting, and KPI analysis
• OT / IT Integration:
  Solid understanding of DCS, PLCs, industrial networks, and SAP/ERP interfaces
• Industrial Infrastructure:
  Experience overseeing backup, recovery, and high-availability architectures for manufacturing systems

• Computer System Validation (CSV):
  Strong working knowledge of GAMP 5 and risk-based validation approaches
• Regulatory Compliance:
  Experience supporting systems subject to:
  • FDA 21 CFR Part 11
  • EU GMP Annex 11
• Data Integrity:
  Understanding of ALCOA+ principles and electronic records management
• Quality Systems:
  Familiarity with Change Control, Deviations, and CAPA within GMP environments

• Education:
  Bachelor's degree in Engineering, Computer Science, or Life Sciences required
  Master's degree or MBA preferred for senior-level candidates
• Experience:
  5–8+ years of project management experience within pharma or biotech manufacturing
• Certifications (Preferred):
  PMP, Lean Six Sigma Green/Black Belt, or equivalent
• Soft Skills:
  Proven ability to coordinate across technical, quality, and business stakeholders
  Strong communication and documentation skills in regulated environments

• Lead mission-critical manufacturing systems that directly impact patient safety
• High-visibility role across Operations, Quality, and IT leadership
• Opportunity to influence digital plant and Industry 4.0 initiatives in a GMP setting
• Work on complex, technically challenging projects at the intersection of automation and compliance

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.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.

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.