Senior Process Engineer

PROCHEM Engineering

Waterford, Ireland

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