One of the worlds largest pharmaceutical companies in Dublin West is searching for a Process Engineer to support their engineering & validation day-to-day operations.
- Acting as an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, validation activities, conducting and leading investigations
- Partaking in specific manufacturing projects that arise on the process, equipment or systems providing a structured lean approach to problem resolution
- Working cross functionally on removing barriers to maintain a highly effective and productive team environment.
- Ensuring consistency between process design and technical SOPs
- Ensuring all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
- Leading Best practice Aseptic Technique principles current with the GXP/ GMP guidelines
- Reporting to management on a regular basis on performance and report any issues that need to be resolved.
- Fostering compliance and schedule adherence to ensure the operational plan is achieved.
- Supporting strategic plans for plant improvements in order to increase efficiency and drive down costs.
- Bachelor’s degree in a technical discipline
- 5+ years’ experience in Aseptic filling operations and/or upstream biotechnology processes in a GMP environment.
- 2+ years’ experience in validation roles.
- Should be knowledgeable of regulatory and GMP requirements.
- Strong project management skills.
- Strong stakeholder management skills.
- A proven ability to get involved in cross functional teams and deliver on tight timelines.
- Excellent influencing/collaboration skills and teamwork mindset.
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / firstname.lastname@example.org
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