Reach your career goals with Eirgen Pharma, your future could be here
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?
Eirgen was founded in 2005 and since then we have continually grown and now employ over 180 employees at our site in Waterford. Our strengths lie in our capability to rapidly introduce new products and add additional volume to existing products - ensuring supply for new product launches and expanding market opportunities.
What makes us different is that while we continue to grow our business we have still maintained that small company feel to our culture which enables us to ensure that our employees are always front and centre in everything we do. By creating a progressive and dynamic working environment, where hard work and enjoyment aren’t mutually exclusive, we have created a high performing, people-centric culture which allows us to work in an environment where the focus is always on ensuring that the patient comes first.
The Person
You are qualified to degree level or equivalent in an engineering discipline and have ideally 2-5 years’ experience in a similar role, ideally in an oral solid dose packaging/manufacturing environment. You possess knowledge of the processes and equipment used in the manufacture and packaging of tablets and capsules, the management of small capital projects and an understanding of integrated validation approaches. Familiarity with Minitab or similar statistics software is an advantage while knowledge of cGMP, EU Annex and GAMP requirements is required.
You show excellent problem-solving skills and attention to detail with an ability to think outside the box. You are customer focused with strong communication, influencing and presentation ability. You are driven, accurate and timely in producing results and can manage tasks and schedules effectively.
The Role
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 centered projects safely, on time and within budget.
You will:
Process Engineering
- Have a 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 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
Working at Eirgen – What to expect
At Eirgen, we have developed a diverse, people-centric, high performance culture where people are enabled to achieve their potential.
If you are working at Eirgen, then we think you’ve got something special.Our employees are high-performing and work as part of a cohesive team, they are dedicated people who are driven to succeed and are rewarded with competitive salaries and an attractive range of benefits including opportunities for career progression and continuing education.
Apply for the above role by sending your CV to opportunities@eirgen.com including the job title in the subject.
**Please note we are only accepting direct applications for this role, no 3rd party/agency CV's**