Lead Validation Engineer (CSV/DeltaV)
Valspec is seeking a Lead Validation Engineer (CSV/DeltaV) to support a major biologics manufacturing operation in the Seattle area.
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.
Key Responsibilities
- 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.
Required Qualifications
- 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.
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.