Process Validation Engineer

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.

Engagement: Valspec consultant placed onsite at a major biopharmaceutical manufacturing site in the Raleigh-Durham, NC area

Location: Raleigh-Durham, NC (onsite)

Type: Contract / consulting — initial term approximately 12 months, with a possibility of extension

Start: ASAP

About The Engagement

Valspec is seeking Process Engineers to support large-scale biologics drug substance manufacturing at a major biopharmaceutical site in the Raleigh-Durham area. We're looking for candidates who can step into an active, fast-moving environment and contribute with minimal ramp-up. Openings across Upstream, Downstream, and Clean Utilities — candidates with a strength in one area are encouraged to apply.

Role Overview

The Process Engineer will provide engineering support to production and startup activities across Drug Substance manufacturing, with a primary focus in one of the following areas depending on team assignment:
Upstream (cell culture/bioreactors), Downstream (purification/chromatography), or Clean Utilities (WFI, clean steam, process gases, and supporting utility systems). This person will partner closely with Manufacturing, Manufacturing Sciences (MSAT), Automation, and Quality to troubleshoot process issues and support equipment and process reliability.

Key Responsibilities

• Provide engineering technical support for assigned process area, specifying equipment and process gaps within existing facility design.
• Troubleshoot production and startup issues, partnering with Manufacturing and Maintenance to minimize downtime and support equipment reliability.
• Support process monitoring and control activities within the assigned functional area, ensuring compliance with cGMP requirements.
• Author and review technical documentation, including SOPs, protocols, deviations, and change controls, within GMP quality systems.
• Support process characterization, technology transfer, and continuous improvement initiatives.

Required Qualifications

• BS in Chemical, Biochemical, Mechanical, or Biomedical Engineering, or a related technical field.
• 5+ years of process or manufacturing engineering experience in a pharmaceutical or biotech GMP manufacturing environment.
• Hands-on experience in at least one of:
  Upstream (cell culture/bioreactor) operations, Downstream (purification) operations, or Clean Utilities systems.
• Working knowledge of cGMP requirements in a regulated biologics manufacturing environment.
• Able to work onsite in the Raleigh-Durham, NC area and be fully productive quickly given the engagement timeline.

Preferred Qualifications

• Large-scale biologics drug substance experience (mammalian cell culture and downstream purification).
• Experience supporting a startup, commissioning, or new-facility environment.
• Familiarity with relevant unit operations depending on focus area: bioreactors and cell culture systems (Upstream); chromatography, UF/DF, and viral filtration (Downstream); or WFI, clean steam, and process gas systems (Clean Utilities).

Salary Range: $70 - $80 / hourly range is an estimate of pay for project-based employment. Range varies based on knowledge, experience, and area of focus. 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…