Validation Engineer; CQV

Validation Engineer (CQV)

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, per missives, and emergency shutdown functions through field execution and control system testing.
• Perform detailed P& 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.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

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.