--- title: 'Validation Engineer (CSV) at Valspec' canonical: 'https://feeny.ai/job/validation-engineer-csv-valspec-non-headquarters-ykwwe98wf2f6' type: 'job' last_seen: '2026-09-08' --- # Validation Engineer (CSV) at Valspec - **Company:** Valspec - **Location:** Non-Headquarters - **Posted:** 2026-07-28 - **Last confirmed live:** 2026-09-08 - **Apply:** https://job-boards.greenhouse.io/valspec/jobs/6129025004 ## Job description 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. Lead Validation Engineer (CSV / DeltaV) Valspec | Seattle, WA Full-Time | Hybrid Client Site Support ## About Valspec 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. Position Summary 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. 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. 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. Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. 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. ## About Valspec ## Company Overview - **One-liner**: Valspec provides end-to-end digital and conventional lifecycle services—validation, compliance, and systems assurance—for highly regulated life sciences organizations. - **Entity Type**: Private (Privately Held) - **Headquarters**: Royersford, Pennsylvania, United States - **Founded**: 1999 - **Founders**: Not publicly available ## Core Business - **Primary industry**: Life sciences services (biopharma, cell and gene therapy, advanced manufacturing) - **Target customers**: B2B – life sciences manufacturers, biotech and pharmaceutical companies - **Mission**: “Deliver trusted lifecycle solutions that streamline digital and conventional systems and drive critical milestones toward market success.” ## Products & Services Valspec offers a suite of lifecycle services, not packaged products. Key service lines include: - **eVLM Implementation & Qualification**: Deploy and qualify compliant electronic validation lifecycle management systems. - **Software & Systems Assurance**: Validation and compliance for enterprise software (e.g., ERP, LIMS, MES). - **Data Governance & Integrity**: Secure and govern critical GxP data. - **IT/OT Infrastructure**: Design, implement, and qualify robust IT and operational technology environments. - **Digital Solutions & AI**: Practical AI and digital solutions to accelerate performance. - **Manufacturing Systems Qualification**: CSV and CQV for manufacturing equipment and automation. - **Specialized Expertise**: Serialization (DSCSA compliance), single-use technologies, upstream/downstream purification, cell culture & fermentation, media & buffer prep, recovery, cleaning & sterilization, continuous manufacturing, fill/finish facilities. ## Market Standing - **Valuation/Market Cap**: Not disclosed - **Key Metric**: Annual revenue of approximately $5.9M (latest estimate); 50 employees; 1,900+ projects executed across 185+ client sites. - **Notable Investors/Partners**: Strategic partnerships with **Blue Mountain** (2024) and **ValGenesis** (2023). Talent sources include AVEVA, RoviSys, Emerson, Novartis, Regeneron, GSK. - **Growth Signals**: 14 active job postings (as of mid-2026); headcount declined 5.5% YoY, but the company continues to hire for validation engineers and project managers. Recent strategic partnerships signal expansion in digital lifecycle solutions. ## Competitive Advantages - **End-to-end lifecycle coverage**: From validation roots to full lifecycle leadership (data governance, IT/OT, digital solutions, AI) under one roof. - **Deep domain expertise**: 25+ years exclusively in life sciences, with repeatable processes for highly regulated environments. - **Quality-first mindset**: 100% commitment to compliance and inspection readiness; known for “precision with purpose.” - **Flexible engagement models**: Short-term support to full lifecycle leadership; on-site, remote, or hybrid delivery. ## Strategic Focus - Expand digital solutions and AI capabilities for life sciences. - Strengthen partnerships (e.g., Blue Mountain, ValGenesis) to deliver integrated manufacturing and validation platforms. - Maintain leadership in compliance and data integrity as regulatory demands evolve. - Continue to invest in talent to support client needs across North America. ## Why Work Here - **Culture**: “People First” – described as a family culture where colleagues are friends, retention is high, and individuality is valued. - **Flexibility**: Work from home, customer sites, or office; variety in day-to-day work. - **Career Development**: Ongoing learning, advancement opportunities, and support for career goals. - **Employee Ratings** (13 reviews on LinkedIn): Overall 3.8/5.0; Work-Life Balance 4.6, Culture 4.2, Career 3.8, Compensation 3.6. - **Impact**: Work on life-changing therapies; projects directly support bringing drugs and treatments to patients. ## Sources 1. [valspec.net – Homepage](https://valspec.net/) 2. [valspec.net – About Us](https://valspec.net/about-us/) 3. [valspec.net – Careers](https://valspec.net/careers/) 4. [valspec.net – Expertise](https://valspec.net/expertise/) 5. [LinkedIn – Valspec Company Page](https://www.linkedin.com/company/valspec) 6. [PR Newswire – Blue Mountain Partnership](https://www.prnewswire.com) (referenced in LinkedIn news, but exact URL not provided; use LinkedIn for news mentions) 7. [PR Newswire – ValGenesis Partnership](https://www.prnewswire.com) (same note) ## Other roles at Valspec - [Digital Manufacturing Readiness Lead](https://feeny.ai/job/digital-manufacturing-readiness-lead-valspec-non-headquarters-df0g8sxrgnss) — Non-Headquarters - [Startup & Operational Readiness Manager](https://feeny.ai/job/startup-operational-readiness-manager-valspec-non-headquarters-k1hhraapgfcm) — Non-Headquarters - [Documentation / Data Lead](https://feeny.ai/job/documentation-data-lead-valspec-non-headquarters-2cmx0ja0y32a) — Non-Headquarters - [CSV Lead](https://feeny.ai/job/csv-lead-valspec-non-headquarters-vfje7m6s3gcc) — Non-Headquarters - [Validation & Compliance Lead](https://feeny.ai/job/validation-compliance-lead-valspec-non-headquarters-c6x1c5fr29xq) — Non-Headquarters - [Automation Program Lead](https://feeny.ai/job/automation-program-lead-valspec-non-headquarters-tr3xz4zmxckk) — Non-Headquarters - [Commissioning & Qualification Lead](https://feeny.ai/job/commissioning-qualification-lead-valspec-non-headquarters-7k5vshebh89s) — Non-Headquarters - [Validation Engineer](https://feeny.ai/job/validation-engineer-valspec-non-headquarters-7mc49wvhe6w8) — Non-Headquarters - [Validation Engineer - Kentucky](https://feeny.ai/job/validation-engineer-kentucky-valspec-non-headquarters-65fxamcdxehh) — Non-Headquarters - [Project Manager – North Carolina](https://feeny.ai/job/project-manager-north-carolina-valspec-non-headquarters-xfh7tc361fxz) — Non-Headquarters