Lead Process Engineer

Role Summary

The Lead Process Engineer will serve as the Operations Responsible within the Manufacturing division, focusing on supporting the design, implementation, qualification, and initiation of new Oral Solid Dosage (OSD) manufacturing processes and equipment.

Working as a Subject Matter Expert (SME) in Process Engineering, the individual will facilitate project execution from the Basis of Design phase through to commissioning and the eventual handover to operations. This role ensures that all process and equipment solutions comply with safety, quality, regulatory, and business standards.

Key Responsibilities

• Serve as the lead Process and Equipment SME for assigned OSD manufacturing systems and machinery.
• Provide technical guidance and risk-informed decision-making during the phases of design, construction, qualification, operational readiness, and introduction of new manufacturing processes under GMP standards.
• Apply expertise preferably in OSD unit operations such as dispensing, blending, granulation, tableting, and cleaning.
• Verify that process and equipment designs meet GMP, quality, safety, and operational criteria.
• Engage in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and equipment qualification efforts as necessary.
• Assist with operational readiness, technology transfer, and process validation procedures.
• Collaborate closely with project teams, equipment vendors, and engineering partners to ensure timely and successful project completion.
• Support the creation and approval of all relevant project, engineering, and operational documentation.

Skills and Experience Required

• Possession of a Bachelor's degree in science or engineering disciplines.
• Between 5 to 7 years of experience in pharmaceutical manufacturing, process engineering, or equipment qualification roles.
• In-depth knowledge of OSD manufacturing processes and machinery is preferred.
• Experience in supporting capital projects, technology transfers, or introducing new equipment.
• Familiarity with Good Manufacturing Practices (GMP), process validation protocols, and Good Engineering Practice (GEP).
• Strong communication, stakeholder engagement, and problem-solving capabilities.
• Willingness and ability to work onsite full-time, including travel to equipment supplier locations or other OSD facilities when required.

Work Arrangement

• Full-time onsite presence at the Athlone location is anticipated, with five working days per week.