Senior Process Engineer

Role Summary:

• A fantastic opportunity has arisen for a Senior Process Engineer to join our client’s Pharmaceutical Site in Co. Waterford.
• The successful candidate will provide process engineering support and project leadership to support internal customers in the day-to-day operations of the organization and site capital projects, enabling delivery of high quality process centered projects safely, on time and within budget.
• Reporting to Engineering & Facilities Manager.

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.

Process Engineering

• Identify and manage process improvements and projects
• Lead in the procurement, introduction, commissioning and qualification of process equipment and subsequent process validations
• Ensure qualification methodology is clear and integrated into the project from URS onwards
• Ensure documentation, training and handover meet the internal customers’ expectations
• Life cycle cost considered in designs for maximum long term efficiency and reliability
• Plan and execute process validation schedules for manufacturing and packaging processes.
• Write and execute documents for the validation of new and existing processes.
• Liaise with contractors/customers when external resources are required to complete validations.
• Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure validation activities are planned and executed in line with applicable deadlines.
• Assist with submission/audit/deficiency responses activities when required, in a timely manner.
• Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
• Generate, analyse and interpret statistical data to verify acceptable criteria has been met and support process validations, CPVs
• Develop testing strategies and rationale for manufacturing and packaging process equipment qualification and process validation.
• Provide technical support/troubleshooting for process and equipment issues.
• Investigate/resolve deviations associated with validation activities.
• Utilise structured problem solving in support of process 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 our 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
• 5+ years’ engineering experience working in an oral solid dose pharmaceutical manufacturing and/or packaging (or comparable) environment
• Process validation (including statistics training) experience is an advantage
• Knowledge of processes and equipment used in manufacturing and packaging of tablets and capsules
• 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
• Minitab or similar statistics software is an advantage
• 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.