Summary:
Our client in Waterford is a biopharma company currently going through an expansion and is looking for a Project Engineer to support and project workstream leadership to support internal customers in the delivery of site capital projects, enabling delivery of high-quality projects safely, on time and within budget. The primary focus will be the capacity expansion project and construction of a high volume OSD manufacturing facility.
Responsibilities: Comply at all times with the Health, Safety and Environmental policy and associated procedures, legislative requirements. Continuously promote a positive safety culture by challenging others to prioritize safety in everything. Ensure safety management is paramount in project delivery processes. Lead by example and take ownership of EHS matters in relation to engineering activities involved in. Ensure all work carried out is in compliance with the required standards, conforming to company policy, cGMP, SOP and regulatory guidelines. Lead by example and take ownership for quality compliance in relation to engineering activities involved in. Ownership of equipment qualification and process validation from a quality compliance perspective. Support the development of project charters and scope definition. Support the management of the schedules and facilitate meetings as required. Ensure project methodology is clear and integrated into the project from initiation onwards. Ensure documentation, training and handover meet the internal customers' expectations. Plan and execute project schedules. Write, execute and review documents as required by the projects. Liaise with contractors/customers when external resources are required to complete project works, acting as site contact. Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure project activities are planned and executed in line with applicable deadlines. Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc. Develop testing strategies and rationale for equipment/facility/system qualification. Investigate/resolve deviations associated with project activities. Utilise structured problem solving in support of project issues & problem resolution. Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform. Develop relationships with contractors, ensure they understand the business and are compliant to site procedures. Report covering schedule, cost control, project scope and risks / mitigations, compiled at appropriate intervals. All project and equipment related information stored centrally. Ensure clear, concise communications with internal & external stakeholders. Qualifications & Experience: Qualified to a minimum of degree level in an engineering discipline. 3-6 years' engineering experience working in an oral solid dose pharmaceutical manufacturing (or comparable) environment. Previous project management experience and/or qualification is a distinct advantage. Knowledge of processes, equipment, facilities and systems used in pharmaceutical manufacturing. Management of small capital projects. Integrating in and leading cross functional teams. Knowledge of cGMP, EU Annex and GAMP requirements. Understanding of integrated validation approaches. Scheduling. Ability to manage multiple conflicting demands and to prioritise accordingly. Focus on supporting internal & external customers in a safe and compliant manner.
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