Biopharma Process Engineer – Fill/Finish & GMP

EFOR; Athlone; On-site; EUR 70,000 - 100,000; Full time

Job summary

EFOR is seeking a Process Engineer to support commercial drug product manufacturing in a cGMP facility. You will operate in sterile/fill-finish environments, qualify equipment, troubleshoot, and drive process improvements across cross-functional teams.

The role requires hands-on experience with utilities, qualification activities, and automation systems. Bachelor’s in Engineering, 3+ years in biopharma, and strong documentation skills are essential.

Qualifications

• Bachelor’s degree in Engineering or related discipline (required); Master’s preferred.
• 3+ years of process engineering experience in cGMP biopharmaceutical/pharmaceutical manufacturing.
• Strong hands-on experience with sterile/fill-finish manufacturing.
• In-depth knowledge of clean/critical utilities and process equipment.
• Proficient with P&IDs/PFDs and technical risk reviews (HAZOP, FMEA).

Responsibilities

• Provide process engineering support for commercial biopharmaceutical manufacturing, including sterile/fill-finish operations.
• Lead and execute equipment and facility qualification activities (FAT, SAT, IQ, OQ, PQ).
• Maintain and optimise clean/critical utilities (WFI, PW, clean steam, CIP/SIP, compressed air, nitrogen).
• Oversee operation and troubleshooting of processing equipment: Autoclave, Parts Washer, FIT, Fill Line, PUPSIT, Formulation.
• Deliver capital engineering projects from design to installation, commissioning, and qualification.
• Develop, review, and update P&IDs/PFDs; participate in technical and risk reviews (HAZOP, FMEA).
• Conduct root-cause investigations, manage deviations, CAPAs, and change controls.
• Collaborate with Manufacturing, Quality, EHS, Automation, and external vendors to ensure effective project and process execution.
• Support GMP documentation, SOP development, and audit/regulatory readiness activities.
• Drive continuous improvement initiatives; Lean Six Sigma/OEE experience preferred.
• Support and troubleshoot automation and control systems (Siemens or Allen-Bradley advantageous).

Skills

Sterile/fill-finish operations

Process engineering

Troubleshooting & deviation management

Regulatory/compliance knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or related discipline

Master’s degree preferred

Tools

P&IDs/PFDs

HAZOP / FMEA

Automation systems (Siemens/Allen‑Bradley)

Job description

EFOR is seeking a Process Engineer to support commercial drug product manufacturing in a cGMP facility. You will operate in sterile/fill-finish environments, qualify equipment, troubleshoot, and drive process improvements across cross-functional teams.

The role requires hands-on experience with utilities, qualification activities, and automation systems. Bachelor’s in Engineering, 3+ years in biopharma, and strong documentation skills are essential.