Process Engineer

EFOR; Athlone; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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).

Connaissances

Sterile/fill-finish operations

Process engineering

Troubleshooting & deviation management

Regulatory/compliance knowledge

Cross-functional collaboration

Formation

Bachelor’s degree in Engineering or related discipline

Master’s degree preferred

Outils

P&IDs/PFDs

HAZOP / FMEA

Automation systems (Siemens/Allen‑Bradley)

Description du poste

Position Overview:

The Process Engineer will play a key role in supporting commercial drug product manufacturing within a cGMP-regulated facility. This position requires hands-on experience in sterile/fill-finish operations, comprehensive process engineering knowledge, and expertise in equipment qualification, troubleshooting, and continuous improvement initiatives. The position will work cross-functionally to ensure robust operations and compliance with regulatory standards.

Key Responsibilities:

• Provide process engineering support for commercial biopharmaceutical or pharmaceutical 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 (exposure to Siemens or Allen-Bradley advantageous).

Qualifications & Experience:

• Bachelor’s degree in Engineering or a related scientific discipline (required); Master’s preferred.
• Over 3 years of process engineering experience in cGMP-regulated 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).
• Excellent troubleshooting/root-cause analysis and deviation management skills.
• Familiarity with GMP, SOPs, and regulatory requirements.
• Continuous improvement experience; Lean Six Sigma/OEE desirable.
• Automation/control-system exposure (Siemens, Allen-Bradley) is a plus.