Process Excellence Lead - Newbridge, Co. Kildare
With a reputed OSD Pharmaceutical Site based in Co. Kildare.
My client is a world leader in the development, manufacture and supply of pharmaceutical products.
All colleagues at the site are committed to the vision of delivering breakthroughs that change patient's lives. We have the development and technical capability to supply complex oral solid dose products to patients across the world. We have a proven track record that has been recognised with major investment and new product transfers. We are proud to be on the leading edge of process and technology development for the making of medicines. We are proud of the positive impact we continue to make on our patient's lives.
Situated in Co. Kildare (30 minutes south of Dublin), the site is an integral part of the global oral solid dose network; manufacturing tablets and capsules for world markets using highly complex processes. This site has been an established leader in the supply of medicines for over twenty five years and is currently expanding its portfolio.
The Technical Services team is recruiting for colleagues to work with us at this exciting time for the facility.
We support the commercial supply and technical transfer of products using a wide range of technologies including Process Analytical Technologies and Advanced Process Control. We continuously improve and enhance our facility through the execution of complex projects introducing next generation manufacturing processes
We have a pilot scale plant (the Technology and Innovation Centre) with the capability of carrying out development at 1kg to 50kg scale across all principle unit operations. We own the validation of the manufacturing and cleaning processes which supply all markets including the USA, EU and Asia. We work in a fast-paced environment where learning and personal development are actively encouraged.
We pride ourselves on our culture of high performance teamwork and innovation which enables the business to deliver on its commitments.
The role will include the following responsibilities:
- The Process Technical Lead is accountable for all technical aspects of the process in a manufacturing area - including process development, robustness and validation.
- The successful candidate will be fully self-directed and will act as a coach to Technical Services Specialists and to the Process Centred Team working in the manufacturing area.
- They will be recognised as having a high level of knowledge/skill in solid dosage manufacturing.
- They will have demonstrated expertise in Systems and Technology Platforms and will have a demonstrated track record of timely major project completion.
- They will provide technical and product input to process teams for timely issue resolution and root cause analysis as required.
- The successful candidate should be able to identify and implement change the business activities and step change process improvements. They will deliver continuous improvement projects using six sigma and lean methodologies
- Identify best practices to support process improvements within the Pfizer network and implement to support process robustness. Ownership of Process Robustness at process centred team level. Accountability for process knowledge management.
- Accountability and Decision Making.
- As a Process Technical Lead approves change controls, investigations, development reports etc. they must demonstrate that they appreciate the impact of actions holistically across Product, Equipment and Systems.
- An appreciation of the compliance, regulatory and business requirements must be included.
Educated to degree level in Science, Pharmacy or a related discipline
Significant experience in the Pharmaceutical industry preferably in solid oral dose manufacture