Lead Process Engineer

Morgan McKinley; Athlone; On-site; EUR 85,000 - 110,000; Full time

Job summary

Morgan McKinley seeks a Lead Process Engineer to drive design, qualification and start-up of OSD manufacturing areas. You will act as Process SME within Process Engineering, delivering safe, compliant and efficient process solutions from BD through commissioning and handover.

Role requires on-site work five days a week in Ireland with travel to supplier sites or other OSD facilities as needed. Strong GMP, process validation and engineering fundamentals are essential.

Qualifications

• Bachelor's degree in science or engineering.
• Minimum 5–7 years pharmaceutical manufacturing, equipment qualification or process engineering experience.
• Strong knowledge of OSD manufacturing processes and equipment is preferred.
• Experience supporting capital projects, technology transfers or equipment introductions.
• Knowledge of GMP, process validation and Good Engineering Practice (GEP).
• Strong communication, stakeholder management and problem-solving skills.
• Flexibility to work on-site full-time, with availability for travel to equipment supplier sites or other OSD facilities if required.

Responsibilities

• Act as Process and Equipment lead SME for assigned OSD manufacturing processes and equipment.
• Provide technical leadership and risk-based decision making during the design, construction, qualification, operational readiness and GMP introduction of new manufacturing processes and equipment.
• Experience with OSD unit operations is preferred, such as dispensing, blending, granulation, tableting or cleaning.
• Ensure process and equipment designs comply with GMP, quality, safety and operational requirements.
• Participate in FAT, SAT and equipment qualification activities where required.
• Support operational readiness, technology transfer and process validation activities.
• Collaborate with project teams, vendors and engineering partners to ensure successful project delivery.
• Support development and approval of project, engineering and operational documentation.

Skills

Process engineering

GMP

Stakeholder management

Problem solving

Communication

Travel flexibility

Education

Bachelor's degree in science or engineering

Job description

The Lead Process Engineer will work as Operation Responsible in the Manufacturing department, supporting the design, introduction, qualification and start-up of new Oral Solid Dosage (OSD) manufacturing process areas and equipment.

Working as Process SME within the Process Engineering team, the role will support project delivery from Basis of Design (BD) through commissioning and handover to operations, ensuring process and equipment solutions meet safety, quality, regulatory and business requirements.

Key Responsibilities

• Act as Process and Equipment lead SME for assigned OSD manufacturing processes and equipment
• Provide technical leadership and risk-based decision making during the design, construction, qualification, operational readiness and GMP introduction of new manufacturing processes and equipment.
• Experience with OSD unit operations is preferred, such as dispensing, blending, granulation, tableting or cleaning.
• Ensure process and equipment designs comply with GMP, quality, safety and operational requirements.
• Participate in FAT, SAT and equipment qualification activities where required.
• Support operational readiness, technology transfer and process validation activities.
• Collaborate with project teams, vendors and engineering partners to ensure successful project delivery.
• Support development and approval of project, engineering and operational documentation.

Skills and Experience Required

(List the specific skills, qualifications, and experience necessary for the role.

• Bachelor's degree in science or engineering discipline.
• Minimum 5 - 7 years pharmaceutical manufacturing, equipment qualification or process engineering experience.
• Strong knowledge of OSD manufacturing processes and equipment is preferred.
• Experience supporting capital projects, technology transfers or equipment introductions.
• Knowledge of GMP, process validation and Good Engineering Practice (GEP).
• Strong communication, stakeholder management and problem-solving skills.
• Flexibility to work on-site full-time, with availability for travel to equipment supplier sites or other OSD facilities if required.

Work Arrangement

• Expectation is that the person will be on site 5 days per week.