Process Engineer

Ref. 1409

Process Engineer

Exciting opportunity to join a leading multinational pharmaceutical company as a Process Engineer at their Dundalk facility.

Role:
Provide support to the Engineering Services Team by delivering process engineering expertise for the design, commissioning, and qualification activities of a new vaccine manufacturing facility. The role contributes to achieving project objectives through collaboration within cross-functional teams.

Key responsibilities include:
• Leading cross-functional teams to deliver project goals;
• Reviewing equipment designs against engineering and regulatory standards;
• Identifying critical gaps and developing technical solutions to ensure compliance;
• Supporting project execution to resolve compliance gaps and address major process equipment issues;
• Working with systems and packages such as Filling Lines, Lyophilizers, Autoclaves, CIP/SIP skids, Bioreactors, UFDF skids, and related equipment.

Role Responsibilities:
• Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
• Ensure all project stakeholders are informed and consulted on key process activities and decisions.
• Monitor progress of deliverables with all team members and provide status reports to project Tiers and stakeholders.
• Oversee C&Q progression of assigned project activities.
• Support the C&Q Lead to coordinate preparation and, at times, lead C&Q field execution.
• For new assigned capital projects;
 Develop and/or review system lifecycle documents including Criticality and Risk assessments, URS, FAT documentation, and C&Q documentation.
 Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
 Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within company’s Manufacturing Network as required to support Project.
 Maintain contact with the Project Sponsors to ensure engineering solution development remains aligned with the project’s business case.
 Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
• The role also involves Project Engineering duties including:
 Preparation of project related deliverables such as schedules, work plans, equipment cost tracking
 Coordination of project activities between stakeholders
• Collaborate closely with cross-functional teams to establish scope for improvement projects as the facility progresses to full commercial operation.
• Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
• May be required to perform other duties as assigned.

Requirements:
• A B.Sc. or M.Sc./M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalent defined as a Biotechnology or Industrial Chemistry degree with the fundamental elements of chemical/biochemical engineering as applied to biotechnology/bioprocessing.
• 3+ years of post-academic experience in process engineering within biopharmaceutical process design, construction, and start-up environments.
• Knowledge and experience in Filling Lines and sterile filling processes or similar manufacturing equipment.
• Demonstrated ability to lead and influence teams in a matrix environment.
• In-depth understanding of process engineering and technologies pertinent to unit operations and utility systems for bulk vaccine processing facilities.
• Lean Six Sigma methodology experience desired.
• Knowledge of process automation, MES, DCS/PLC platforms, and industry-standard SDLC methodology.
• Knowledge of regulatory and code requirements, including Irish, European, and international standards and practices.
• Excellent written and verbal communication skills, including report, standards, and policy documentation, with strong interpersonal abilities to interface effectively with colleagues and external partners.
• Proficiency in Microsoft Office and other job-related computer applications.
• Strong safety ethos.
• Proven project and people management skills, including planning, team leadership, and coordination of contractors and vendors to deliver on time, schedule, and budget.
• Strong attention to technical detail and ability to contextualize within overall deliverables.