Process Validation Engineer

Valspec; Redwood City (CA); In loco; USD 103.000 - 117.000; Part-time

Vantaggi offerti da questo lavoro

Premium medical coverage

401(k) with company match

ESOP

Descrizione del lavoro

Valspec, a global provider of system validation and lifecycle services, seeks a Senior Process Validation Engineer (Contract) to support large-scale biologics drug substance manufacturing at a Northern California biotech site. This onsite engagement requires a senior candidate who can own PPQ and CPV deliverables with minimal ramp-up.

Role spans the full validation lifecycle from design through CPV, partnering with MSAT, Manufacturing, QA and Process Development in a GMP setting. Start ASAP.

Competenze

• BS in Chemical, Biochemical, Biomedical Eng or related field.
• 8+ years of process validation in pharma/biotech GMP.
• Hands-on PPQ protocol authoring & execution.
• Knowledge of FDA process validation guidance.

Mansioni

• Author, execute, and report PPQ protocols.
• Support lifecycle from design to CPV.
• Develop control strategies and CPV trending.
• Ensure GMP documentation readiness.

Conoscenze

PPQ protocols

GMP writing

Statistical analysis

FDA process validation guidance

On-site work

Formazione

BS in Chemical/Biochemical/Biomedical Eng or related

Strumenti

Minitab

JMP

Descrizione del lavoro

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.

Senior Process Validation Engineer (Consultant) — Contract

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

Location: Northern CA (onsite)

Type: Contract / consulting — initial term approximately 6–7 months, with a strong likelihood of extension

Start: ASAP

About the Engagement

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.

Why this engagement stands out:

• 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).

Role Overview

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.

Key Responsibilities

• Author, execute, and report on PPQ protocols for drug substance manufacturing processes.
• Support the full process validation lifecycle — Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification).
• Develop and maintain control strategy elements, process monitoring plans, and CPV trending.
• Perform statistical analysis of process data (capability, trending, limits) using Minitab or JMP.
• Author and review validation deviations, investigations, CAPAs, and change controls within GMP quality systems.
• Partner cross‑functionally with MSAT/Manufacturing Sciences, Manufacturing, QA, and Process Development to align validation activities with production schedules.
• Support process characterization and tech‑transfer activities as needed.
• Ensure all work complies with FDA process validation guidance, ICH Q8–Q12, and EU GMP (Annex 15).
• Maintain accurate, audit‑ready GMP documentation and validation records.

Required Qualifications

• BS in Chemical, Biochemical, or Biomedical Engineering, Biology, Biochemistry, or a related technical field.
• 8+ years of process validation experience in a pharmaceutical or biotech GMP manufacturing environment, at a senior/lead level.
• Hands‑on experience authoring and executing PPQ protocols and reports.
• Working knowledge of the process validation lifecycle and current FDA process validation guidance.
• Statistical analysis experience using Minitab or JMP.
• Strong GMP technical writing skills.
• Able to work onsite in Northern California and be fully productive from day one given the short engagement window.

Preferred Qualifications

• Large‑scale biologics drug substance experience (mammalian cell culture and downstream purification).
• Prior experience at a large‑scale commercial biologics manufacturer.
• Familiarity with relevant unit operations: bioreactors, chromatography, UF/DF, viral filtration.
• Experience with electronic batch records / MES and validation lifecycle management systems.

What Makes a Strong Fit for This Engagement

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.

Join Us

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.

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
• 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.

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.

The application deadline for this role is November 7, 2026