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Aseptic Manufacturing Associate

2 months ago

Dublin, Ireland Amgen Full time

Associate Manufacturing (24/7 shift) FTC - Amgen Dun Laoghaire - Co. Dublin

Overview of Amgen:

AMGEN: A Pioneer in Biotechnology Manufacturing

Ensuring that Amgen medicines reliably and safely reach “every patient, every time” is the charge of Amgen’s manufacturing organization. From the beginning, the company’s contributions to the emerging field of biotechnological production of human therapeutics have been driven by a strong commitment to meeting the needs of patients. From process development to clinical manufacturing and full-scale therapeutic protein production, the company has built one of the industry’s largest and most reliable operations.

Amgen Dún Laoghaire (ADL)

• ADL is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – formulation, fill, and packaging. The ADL site also includes laboratories and cold chain warehouse capabilities.

• There is a strong culture of continuous improvement and innovation within the plant

• We are proud of our award-winning environmental sustainability programme

• Amgen is developing the capability to produce all of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally

Overview of the job:

The PM3 Syringe Manufacturing Associate will report to the 24/7 Front Line Manager (FLM) and will be responsible for ensuring continuity and standardisation 24x7 of operations. The Associate Manufacturing (Level 3) is a Senior Operator position at Amgen Dun Laoghaire (ADL) and forms part of the manufacturing shift working on a 24/7 shift rotation involved in formulation and aseptic Filling of biopharmaceuticals (Syringes) in compliance with Good Manufacturing Practices. The Associate Manufacturing will develop as a SME/lead Operator in a process area within ADL Manufacturing (Formulation, filling, Lyophilisation, Sterilisation) ensuring that all activities are completed to highest standards in Environmental, Health and Safety, Quality and Compliance, Operational Excellence and building on a culture of diversity, inclusion and belonging in the Manufacturing department at Amgen Dun Laoghaire – Dublin. Please note this is a Fixed Term Contract (FTC) role for 12 months.

The ideal candidate will have (Basic Qualifications):

  • Working knowledge of aseptic or GMP manufacturing operations, typically 2 - 5 years experience with demonstrated performance

  • Have the ability to lead a manufacturing unit operation as a Lead Operator to deliver both tactical and strategic objectives to ensure patient supply today and into the future.

  • 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.

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

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

  • Strong computer skills - knowledge of Electronic Batch Records, PAS-X, Lims, etc.

The ideal candidate will have the following (Preferred skills and qualifications):

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

  • Good mechanical aptitude

  • Excellent problem solving skills

  • Ability to work in a team environment and on one’s own initiative

Deliver Results:

  • Responsible for coordination and execution of activities in assigned subject matter expert process area to achieve the production targets and schedule in drug product formulation, filling, lyophilisation and capping including supporting processes (component preparation and sterilisation, sterile filtration, CIP/SIP and filter integrity tests)

  • Responsible for completing pre task briefings with the operations team ensuring all tasks are executed safely and in compliance with the Amgen Quality system. Completion of post task review and highlight any areas where the task deviated from standard work or any safety/quality error traps.

  • Responsible for tracking the performance of assigned process area during their shift, including reviewing, updating area performance boards and management of issues impacting delivery of the manufacturing plan.

  • Responsible for ensuring all team members are supported and coached in the subject matter area and providing clear direction and feedback as required to help develop the team.

  • Develop expertise in systems required to support delivery of the manufacturing schedule including automation and Management Execution Systems (e.g. PAS/X, EDMQ, OEE, QTMS & PI)

  • Responsible for the operation, cleaning and sanitisation of process equipment and where required the associated aseptic area. (Including execution of validation protocols).

  • Support, as SME, investigations into manufacturing operations including Formulation, Filling, and Parts Preparation.

  • Effectively communicate relevant information to peers, manufacturing operators, cross functional departments, and manufacturing management building collaborative relationships within his/her team and other departments.

Ensure Safety, Quality, and Compliance:

  • Takes a proactive approach to safety, quality and compliance and actively seeks opportunities to prevent adverse events from occurring.

  • Responsible for complying with all cGMP requirements as specified by the ADL Quality Management System and escalating any GMP concerns or potential non-conforming events that occur during their shift and has occurred.Responsible for as SMEs initiating or participating in problem solving exercise to support non-Conformances or improvement areas (e.g. 5 Whys Exercise, Awareness Sessions).

  • Foster an excellent Safety culture and act as a safety role model for safe behaviours and actions creating a culture of trust, respect, diversity and inclusion

  • Act as aseptic coach for the operations team through observation and advising on aseptic practices in the manufacturing area.

  • Contribute to and assist with Corporate, FDA, HPRA and other regulatory bodies during GMP audits.

Continuous Improvement:

  • Responsible for taking the lead in the resolution of daily production issues and supporting implementing recommended process/product improvements.

  • Lead effective problem solving for issues that affect the achievement of department objectives and establish and implement of counter measures.

  • Be a role model for lean initiatives to continuously improve the manufacturing department and achievement of its objectives and value position.