Validation Engineering

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

Benefits

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.

Candidate Eligibility
Candidates must be legally eligible to work in the United States without company sponsorship. We are not interested in working on a corp‑to‑corp basis with other companies at this time.

Equal Opportunity Employer
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.

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