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Amgen Sr. Associate Process Development (12 month FTC) in Dublin, Ireland

PD Inspection Sr. Associate (Level 4) – 12 month FTC

Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and groundbreaking spirit that marked our early days as a biotechnology innovator. We support our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities. Our process development inspection team in Amgen Dun Laoghaire is responsible for the ongoing support and development of the best inspection methods and techniques that supports the release of our life saving products to our patients.

Currently we are looking for a process development inspection associate that can help us bring the inspection areas here in Dun Laoghaire Ireland to the next level.

This position will report to the PD inspection Senior Engineer. The ideal candidate will provide strong management and leadership in the Inspection area. Previous experience in a supervisory role is a distinct advantage.

What are your responsibilities as PD Inspection Sr. Associate?

  • Performs processes and associated tasks according to Standard Operating Procedures, demonstrates a higher level of responsibility for the performance of the production area related to inspection and or packaging.

  • Responsible for coordination of the shift / area to achieve the PD related targets and schedule, ensuring staff members are given clear direction, motivation and feedback as required.

  • Responsible for the performance of the PD shift / area, including reviewing, updating area performance boards, and timely feedback to the team and management where issues or opportunities occur.

  • Report concerns to PD senior engineer in relation to resources allocated/available in the area responsible for compiling all necessary reports (paper or electronic) and documentation relevant to the manufacturing area.

  • Support the development of robust and accurate procedures by being the SME to ensure updates occur when required (e.g. Red-lining of SOPs, Batch records / EBRs)

  • Support the area performance by being able to work with facility related computer or automation systems to identify or trend Inspection performance (e.g. EDMQ, OEE, QMTS & PI).

  • Support, as SME, manufacturing operations including but not limited to Capping, and Inspection.

What are we looking for in a person?

  • Good team player

  • Clear communication skills both written and oral

  • Good understanding of inspection and equipment used in (pharmaceutical) inspection industry

  • Good understanding of the link between inspection with filling & capping and packaging

  • Applies analytical skills to evaluate and interpret complex situations and problems

  • Manages multiple assignments and processes

  • Independently determines approach to projects

  • Recognizes and escalates problems

  • Contributes to (project)team by ensuring quality of tasks/services provided by self and others

  • Give support to the completion of milestones associated with specific projects or activities within own department or project team.

What do you bring to the table?

  • Educated to diploma level or equivalent in an appropriate discipline.

  • Experience working in an inspection and/or packaging supervisory role and have a working knowledge of automated visual inspection equipment from vendors such as EISAI, Brevetti, Seidenader and WILCO.

  • Have a commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates.

  • Be an effective problem solver who is capable of leading complex investigations and driving countermeasures through to closure to prevent re-occurrence.

  • Have a passion for embracing a culture of diversity, inclusion and belonging within our workforce.

  • Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.

  • Strong ability to lead, challenge and positively influence in an interactive team environment

  • Strong computer skills - knowledge of Eisai or Brevetti would be an advantage, Word/ excel/ minitab, QMTS, etc.

  • Applicants should have relevant experience of operation of a manufacturing function in a pharmaceutical manufacturing or similar environment.

  • Be a results-oriented person with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.

  • Demonstrated ability to deliver to team, site and personal objectives.

  • Ability to assemble, disassemble, operate and understand equipment per procedures

  • Intermediate mathematical skills

  • Clear, concise writing skills

  • Organizational skills

  • Practitioner level in problem solving skills

  • Ability to interact constructively with peers

  • Ability to understand, apply, and evaluate the basic principles of Biotechnology in an inspection capacity

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.