Back to jobs
New

Validation Engineer (CSV)

Non-Headquarters

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.

Create a Job Alert

Interested in building your career at Valspec? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

U.S. Citizens should select No to this question. Please select Yes or No to designate whether you require sponsorship to work for any U.S. employer, now or in the future.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Valspec’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

The application deadline for this role is August 28, 2026