Process Validation Engineer

Engagement: Valspec consultant placed onsite at a biotech manufacturing site in Northern California.

Valspec is seeking a Senior Process Validation Engineer to support large-scale biologics drug substance manufacturing at a major biotech site in Northern California. This is a consulting engagement supporting an active validation effort, so we need a senior-level candidate who can hit the ground running — owning validation deliverables independently in a GMP environment with minimal ramp-up.

High-visibility validation work at a major biotech site.

Initial 6–7 month term with a strong likelihood of extension (not guaranteed, but the work pipeline points that way).

The Senior Process Validation Engineer will independently author and execute process validation deliverables across the validation lifecycle, partnering closely with Manufacturing Sciences (MSAT), Manufacturing, Quality, and Process Development. As a senior individual contributor, this person is expected to own deliverables with minimal oversight and drive cross-functional alignment. The role centers on Process Performance Qualification (PPQ) and Continued Process Verification (CPV) for commercial drug substance processes, with an emphasis on right-first-time documentation and on-time execution.

Because this is a focused, senior-level engagement, the ideal candidate is a career consultant or contractor who has owned PPQ campaigns end-to-end and can be fully productive almost immediately — there isn't runway for a long ramp. Prior large-scale biologics drug substance experience and recent contract history are strong positive signals. Local or relocation-ready candidates are preferred given the onsite requirement in Northern California.

Salary Range: $75 - $85 / hourly range is an estimate of pay for project-based employment. Range varies based on knowledge and experience. Higher rates possible for short-term assignments and independent contractors. If you are a dedicated Process Engineer with a passion for ensuring the quality and compliance of manufacturing processes in the biopharmaceutical industry, we want to hear from you! Join us on our mission to revolutionize medicine and transform lives. Apply now to be part of a dynamic team driving innovation in California and beyond.

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.