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.

Validation Engineer (CQV)

Location: Raleigh-Durham area, NC

Position Overview

We are seeking an experienced Validation Engineer (CQV) to support commissioning, qualification, and startup activities for a large-scale biopharmaceutical manufacturing facility. This role will focus on downstream process systems and requires strong hands-on field execution, system troubleshooting, and automation verification experience in a GMP-regulated environment.

Key Responsibilities

Perform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, and utility connections to confirm system accuracy and readiness ahead of commissioning and startup.
Lead and execute mechanical completion walkdowns and turnover package (TOP) reviews, ensuring construction quality, punch list closure, calibration records, weld documentation, and redline updates are complete.
Support commissioning readiness by validating system boundaries, flow paths, and equipment installation in alignment with design documentation.
Execute commissioning and qualification (CQV) activities for downstream process equipment including:

Chromatography skids
Ultrafiltration/Diafiltration (UF/DF) systems
Viral filtration systems
Depth filtration units
Buffer preparation vessels
Product hold tanks

Perform field startup and functional testing of chromatography systems, including:

Flow path verification
Valve sequencing checks
Conductivity and pressure monitoring
Automation functionality validation

Conduct Operational Qualification (OQ) testing for automated systems using DeltaV, including:

Loop checks and I/O verification
Interlock and permissive testing
Alarm challenge testing
Control logic and sequence verification under live conditions

Verify process alarms, interlocks, permissives, and emergency shutdown functions through field execution and control system testing.
Perform detailed P&ID walkdowns and field verification of valves, instruments, and process flow to support system turnover, TOP approval, and final acceptance.
Identify and troubleshoot startup issues related to:

Automation logic and control sequences
Valve sequencing and flow path discrepancies
Equipment integration and skid interfaces
Cleaning cycle performance

Collaborate cross-functionally with engineering, construction, and operations teams to maintain project timelines and ensure successful system startup.

Required Qualifications

Bachelor’s degree in Engineering (Chemical, Mechanical, or related discipline) or equivalent industry experience
5+ years of experience in CQV, commissioning, or validation within biopharmaceutical or life sciences manufacturing
Hands-on experience with downstream processing equipment, especially chromatography and filtration systems
Strong knowledge of cGMP requirements, commissioning processes, and validation lifecycle
Experience executing OQ protocols and field testing activities
Familiarity with DeltaV or similar DCS platforms (Emerson experience preferred)
Proficiency in reading and interpreting P&IDs, isometrics, and technical drawings
Demonstrated ability to work in a fast-paced startup environment with significant field presence

Preferred Qualifications

Previous experience supporting greenfield or large-scale capital projects
Strong troubleshooting and problem-solving skills in live plant environments
Experience with automation systems integration and process control verification
Ability to manage multiple systems and priorities during commissioning/startup phases

Work Environment

Primarily field-based role with significant time in manufacturing and construction areas
Requires coordination with multiple stakeholders across CQV, engineering, and operations
May involve extended hours during critical commissioning and startup windows

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.

Validation Engineer

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