Process Engineer

Role Summary:

• A fantastic opportunity has arisen for experienced Process Engineers to join our client’s Pharmaceutical Site in Co. Waterford.
• Provide project engineering 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.
• Primary focus will be the capacity expansion project, construction of a high volume OSD manufacturing facility.

Core Duties and Responsibilities:

• Health & Safety
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures, legislative requirements.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Ensure safety management is paramount in project delivery processes
  • Lead by example and take ownership of EHS matters in relation to engineering activities you are involved in.
• Quality Compliance
  • 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 you are involved in.
  • Ownership of equipment qualification and process validation from a quality compliance perspective.
• Project Engineering
  • 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.
• Contractor Coordination
  • Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform under your behest.
  • Develop relationships with contractors, ensure they understand the business and are compliant to site procedures.
• Reporting and Governance
  • 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.

Minimum Qualifications and 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. systems used in pharmaceutical manufacturing
• Management of small capital projects
• Problem solving
• 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
• Motivating others positively
• Ability to work independently and in teams
• Natural influencer
• Be driven by task / project and will show flexibility to ensure results are achieved
• Thinking ‘outside the box’
• Self-starter and accustomed to setting personal goals

Please note, we do not require agency assistance with this role.