Validation Engineer (CSV)

Valspec is seeking a Lead Validation Engineer (CSV/DeltaV) to support a major biologics manufacturing operation in the Seattle area., * Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems.

• Develop and execute validation deliverables including:
• Validation Plans
• Risk Assessments
• Requirements Traceability Matrices (RTMs)
• Installation & Operational Qualification Protocols (IQ/OQ/IOQ)
• Validation Summary Reports
• Support DeltaV system implementations, upgrades, expansions, and modifications.
• Review and approve engineering documentation, functional specifications, design specifications, and configuration documentation.
• Coordinate validation activities across Automation, Engineering, Manufacturing, IT, and Quality organizations.
• Lead protocol execution, deviation investigations, issue resolution, and documentation closeout.
• Support change control activities and validation impact assessments.
• Provide technical guidance and mentorship to junior validation engineers.
• Drive risk-based validation and software assurance practices aligned with current industry expectations.
• Support startup, commissioning, qualification, and operational readiness activities.
• Participate in project planning, scheduling, resource coordination, and stakeholder communications.

This role is ideal for a senior validation professional with extensive DeltaV experience and a proven track record leading validation activities within GMP-regulated pharmaceutical and biotechnology facilities. The successful candidate will provide technical leadership for computerized system validation efforts, support project execution, and work closely with Automation, Engineering, Manufacturing, Quality, and IT teams to ensure compliant system implementation and operation. The role includes both strategic validation planning and hands-on protocol development and execution., * Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical discipline.

• 8+ years of Computer System Validation experience within a GMP-regulated pharmaceutical or biotechnology environment.
• Hands-on DeltaV validation experience is required.
• Experience leading validation projects and coordinating cross-functional teams.
• Proven experience developing and executing:
• Validation Plans
• Risk Assessments
• RTMs
• IQ/OQ Protocols
• Validation Summary Reports
• Strong knowledge of:
• GAMP 5
• CSA and CSV methodologies
• 21 CFR Part 11
• Data Integrity principles
• GMP documentation practices
• Excellent technical writing, communication, and client-facing skills.

Preferred Qualifications

• DeltaV Batch experience.
• Experience supporting biologics or pharmaceutical manufacturing facilities.
• Experience with:
• MES platforms
• Manufacturing automation systems
• Infrastructure qualification
• Commissioning & Qualification activities
• Consulting experience within regulated life sciences environments.
• Previous experience serving as a Validation Lead or Project Lead., 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.

Pulled from the full job description

• Tuition reimbursement
• Health insurance
• 401(k) matching
• Employee stock ownership plan, 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.

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., Valspec, part of the Proconex family of companies, is a leading provider of Computer System Validation (CSV), Computer Software Assurance (CSA), Commissioning & Qualification (CQV), and manufacturing systems consulting services for the life sciences industry. Valspec partners with pharmaceutical and biotechnology manufacturers to deliver compliant, reliable, and efficient systems throughout the project lifecycle.