Process Engineer
Reach your career goals with Eirgen Pharma, your future could be here!
About Eirgen Pharma
Would you like to be part of a company that has the courage, innovation, and capability to improve and enhance patient lives across the globe?
Founded in 2005, Eirgen Pharma employs over 180 people in Waterford. We combine the agility of a small company with the ambition to deliver high-quality medicines globally — all within a collaborative, people-focused culture.
About this Opportunity
You 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 centred projects safely, on time and within budget.
Key Responsibilities:
Process Engineering
- Customer centric approach
- Ensure life cycle cost considered in designs for maximum long term efficiency and reliability
- Identify stakeholders and ensure scope is understood, communicated, approved and locked through appropriate charter for the project
- Highlight and mitigate risks as early as possible
- Manage project budgets to ensure control is maintained at all times
- Manage process improvements and projects approved change control for any changes
- Ensure the quality of all works completed is to the highest standards and on schedule
- Ensure all documentation is appropriately reviewed and signed off
- Organise, coordinate, facilitate and execute qualification related activities as required
- Ensure validation methodology is clear and integrated into the project from URS onwards
- Ensure documentation, training and handover meet the internal customers’ expectations
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
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 com-pliant to site procedures
Reporting and Governance
- Report covering schedule, cost control, project scope and risks / mitigations, compiled at ap-propriate intervals
- All project and equipment related information stored centrally
- Ensure clear, concise communications with internal & external stakeholders
About you
- Minimum degree level in Engineering
- 5+ years in process engineering
- Knowledge of cGMP, EU Annex and GAMP requirements is required
- Experience in oral solid dose packaging/manufacturing environment
- Experience in a GMP-regulated analytical or pharmaceutical environment
- Familiarity with Minitab or similar statistics software is an advantage
Why Join Eigen Pharma?
- You will work as part of a collaborative analytical team, contributing to high-quality data delivery in a fast-paced, GMP-regulated environment
- Opportunity to work on development-stage and commercial products
- Collaborative and quality-driven environment
- Excellent benefits, pension, health insurance, social club, canteen facilities
Apply for the above role by sending your CV to opportunities@eirgen.com including the job title in the subject.