Biopharma Onsite Process Engineer - Upstream/Downstream

Valspec; Raleigh (NC); On-site; USD 96,432 - 110,208; Full time

Benefits offered by this job

Premium medical coverage

401(k) with company match

Tuition reimbursement

Performance incentives

Job summary

Valspec is a global provider of system validation and lifecycle services, offering commissioning and qualification of computerized systems for Life Sciences clients.

This contract consulting role supports large-scale biologics drug substance manufacturing at a major site in the Raleigh-Durham area, across Upstream, Downstream, or Clean Utilities, with strong emphasis on rapid ramp-up and collaboration with MSAT, Automation, and Quality teams.

Qualifications

• BS in Chemical, Biochemical, Mechanical, or Biomedical Engineering or related technical field.
• 5+ years of process or manufacturing engineering experience in pharmaceutical or biotech GMP manufacturing.
• Hands-on experience in Upstream, Downstream, or Clean Utilities.
• Working knowledge of cGMP requirements in a regulated biologics environment.
• Able to work onsite in the Raleigh-Durham, NC area.

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.

Skills

Process engineering

GMP manufacturing

Onsite work

Technical documentation

Education

BS in Chemical Engineering

Job description

Valspec is a global provider of system validation and lifecycle services, offering commissioning and qualification of computerized systems for Life Sciences clients.

This contract consulting role supports large-scale biologics drug substance manufacturing at a major site in the Raleigh-Durham area, across Upstream, Downstream, or Clean Utilities, with strong emphasis on rapid ramp-up and collaboration with MSAT, Automation, and Quality teams.