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Production Operative -Level 1

Production Operative -Level 1

CplMeath
15 days ago
Job description

Duties -

  • The production of biologic drug substance on their designated shift team and will be responsible for

the preparation, operation and monitoring of equipment, use of business systems and carrying out

tasks including but not limited to the cleaning, validation, in-process testing.

  • The progression of an automated recipe using paperless technology in order to generate the drug

    • substance through inoculation and cell culturing activities directing to filtration and purification of the

    product.

  • Setting up the single use equipment between runs, carrying out the production process according to

    • world class GMP and EHS standards and driving to optimise and improve the processing activities

    through use of standard work and lean processing techniques.

  • Focusing on delivery to the patient through living the Dunboyne culture including a commitment to

    • safety, focusing on right first time in everything we do and concentrating on the engagement and

    development of self and peers.

  • Maintain a high standard of safety / GMP compliance at all times.
  • Maintain a high level of personal expertise and working knowledge of all aspects of the

    • manufacturing process and process equipment through continuous training and development.

  • Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the

    • manufacturing process plan.

  • Support approved projects and continuous improvement initiatives that are in alignment with site

    • strategies.

  • Be an advocate for continuous improvement
  • Experience in a highly regulated pharmaceutical manufacturing environment
  • Good understanding in the production of biologic drug substance and experience an advantage.
  • Ability to work as part of a shift team and on own initiative in a constructive manner.
  • Ability to think logically and be proactive under pressure.
  • Flexible and self-motivated

    • Requirements -

  • A science qualification in a technical, engineering or science-based discipline or equivalent.
  • 0 to 3 years’ experience in the biotechnology and / or pharmaceutical industry or equivalent

    • Shift is 24 / 7 - 4-Cycle shift -

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    Production Operative • Meath