Validation Engineer

About the role

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.

Responsibilities

• Author, review, and execute CSV protocols (IQ/OQ) and validation lifecycle documentation for DeltaV automation systems and related computerized systems
• Support system changes, upgrades, and periodic reviews through the change control process, ensuring validated state is maintained
• Perform and document test execution, including tracking and resolving discrepancies and deviations
• Develop and maintain requirements documentation, traceability matrices, and validation summary reports
• Ensure documentation and testing align with cGMP, GAMP 5, and data integrity (21 CFR Part 11) expectations
• Collaborate with automation engineers, Quality, and Manufacturing teams to keep validation deliverables on schedule
• Support audit readiness and respond to quality review findings related to computerized systems

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related discipline
• 2–4 years of validation or CSV experience in a pharmaceutical, biotech, or other GMP-regulated manufacturing environment
• Hands-on experience authoring and executing validation protocols and lifecycle documentation
• Working knowledge of GAMP 5, cGMP requirements, and data integrity principles (21 CFR Part 11)
• Experience with Emerson DeltaV or a comparable distributed control system (DCS)

Qualifications

• Preferred: Experience with change control, deviation management, or CAPA processes
• Familiarity with electronic document management systems (CDMS/EDMS)
• Experience with validation lifecycle management tools (e.g., Kneat, ValGenesis)
• Prior consulting or contract experience in pharmaceutical manufacturing

Benefits

• Competitive hourly rate
• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives

Pay

Competitive hourly rate, discussed during the screening process

Schedule

Standard business hours