Process Validation Engineer

About the role

Valspec is seeking Process Engineers to support large-scale biologics drug substance manufacturing at a major biopharmaceutical site in the Raleigh-Durham area. The role involves providing engineering support for assigned process areas, troubleshooting production and startup issues, and supporting process monitoring and control activities.

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.

Requirements

• 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.

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).

Skills

Not specified

Benefits

Not specified

Pay

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.

Schedule

Not specified