Process Engineer – Drug Product (Formulation)

Ref. 1336

Process Engineer (DP Engineer – Formulation)

Exciting opportunity with our client, a leading multinational pharmaceutical company, for an experienced Process Engineer (DP Engineer – Formulation) to join their team at the Dundalk facility. This is an 11-month contract opportunity.

Responsibilities include:

• Provide technical leadership within a newly Vaccine Drug Product Manufacturing site.
• Review and/or develop testing protocols, reports and applicable manufacturing SOPs.
• Create and execute documentation for cGMP activities such as risk assessments /reports.
• Ensure all equipment installed is safe, effective and in compliance with industry standards.
• Lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP.
• Oversee equipment suppliers, including coordination of on-site service activities, continuous improvement initiatives, and critical spare part reviews.
• Support establishment of new PMP for equipment in Drug Product suite.
• Identify process and equipment improvements and develop these into CI projects.
• Lead/participate in, TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings.
• Assist in the transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes.
• Provide technical expertise to defend systems, change controls, investigations and qualification packages during regulatory inspections e.g. FDA, HPRA inspections.

Requirements:

Technical Requirements:
• 5+ years of industrial/engineering experience in a cGMP environment.
• Bachelor’s degree in Engineering or a related technical discipline.
• Experience with equipment qualification and validation activities (FAT, SAT, IQ/OQ).
• Hands-on equipment engineering experience, preferably with autoclaves, parts washers, and formulation equipment.
• Practical skills in equipment support, troubleshooting, repair, and service.
• Experience applying root cause analysis and continuous improvement methodologies (e.g., Six Sigma) in complex technical investigations.
• Experience using risk-based approaches in manufacturing, including tools such as FMEA.

Other Requirements / Skills:
• Manage change controls, deviations, and related documentation as required.
• Direct interface with vendors.
• Ability to adapt to changing priorities and project demands.