Sterile Manufacturing Operations Specialist

5 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeManufacturing Full time €56,000 - €84,000
Job Overview

The Sterile Manufacturing Operations Specialist will be responsible for operating and setting up manufacturing equipment, processing parts and components, performing transactions in electronic systems, and maintaining clean production areas.

Main Responsibilities:
  • Perform all operations with due care and attention, adhering to Good Manufacturing Practices (GMP) and industry standards.
  • Problem solving and troubleshooting, including initiation and documentation of investigations.
  • Responsible for self-inspection during Quality & Safety Audits within their functional area.
  • Contribute to audits with regulatory bodies.
  • Participate in the learning and development program, including annual reviews and goal setting via a performance management process.
  • Support team members in cross-functional training.
  • Owning the use, review, revision, and upgrade of operational documentation and peer review of operations.
Key Requirements:
  • Educated to Leaving Certificate standard or equivalent, including Mathematics & English.
  • A third-level qualification in a relevant subject area would be advantageous.
Experience:
  • Relevant experience in operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.
  • At least 2 years of experience in a GMP/regulated environment.
  • Demonstrated knowledge of GMP principles.
  • Aseptic knowledge in GMP areas.
  • Drug product manufacturing experience.
  • Experience working with equipment used in parenteral products, such as autoclaves, filling lines, and formulation vessels.
Benefits:

This role offers opportunities for professional growth and development. The successful candidate will contribute to a dynamic team environment and work closely with colleagues to achieve common goals.

What We Offer:

We provide a supportive and inclusive workplace culture, enabling our employees to thrive and reach their full potential. Our company values diversity, equity, and inclusion, and we are committed to creating a workplace that is welcoming and respectful to everyone.

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