Senior Process Controls Engineer - Pilot Plant Leader

MRINetwork; Aiken (SC); On-site; USD 110,000 - 160,000; Full time

Job summary

MR Lowcountry, LLC seeks a Senior Process Controls Engineer to support manufacturing operations in a cGMP biotech environment near Aiken, SC. This hands-on leader drives capital and facility projects from concept through commissioning, partnering across Process Development, Manufacturing, Quality, EHS, and Facilities.

Responsibilities include end-to-end project leadership for pilot plant capital, equipment, and facilities; developing charters and schedules; vendor management; and ensuring

Qualifications

• Bachelor’s degree in Chemical, Biochemical or Mechanical Engineering or closely related discipline.
• 6–8 years progressive engineering experience in biotech, pharma, or life sciences manufacturing.
• Experience managing capital projects ($500K–$5M+) in a cGMP environment.
• Proficiency with bioprocessing equipment and unit operations.
• Knowledge of FDA cGMP regulations, GEP, IQ/OQ/PQ lifecycle.
• Experience authoring P&IDs and equipment specifications.

Responsibilities

• Lead end-to-end pilot plant capital, facility, and equipment projects with scope, schedule, budget, and vendor management.
• Develop charters, schedules, risk registers, and change control documentation.
• Coordinate procurement, installation, qualification, and commissioning activities.
• Provide technical support for pilot plant equipment and systems; perform RCA and implement CAPA.
• Ensure work adheres to cGMP and regulatory standards; support inspections and audits.
• Mentor junior engineers and drive continuous improvement in operations.

Skills

Project leadership

Bioprocess equipment knowledge

Regulatory compliance

Root cause analysis

P&IDs & documentation

Cross-functional collaboration

Education

Bachelor’s in Chemical Engineering

Bachelor’s in Biochemical Engineering

Bachelor’s in Mechanical Engineering

Tools

MS Project

Smartsheet

Microsoft Office

Job description

MR Lowcountry, LLC seeks a Senior Process Controls Engineer to support manufacturing operations in a cGMP biotech environment near Aiken, SC. This hands-on leader drives capital and facility projects from concept through commissioning, partnering across Process Development, Manufacturing, Quality, EHS, and Facilities.

Responsibilities include end-to-end project leadership for pilot plant capital, equipment, and facilities; developing charters and schedules; vendor management; and ensuring