Manufacturing Process Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeAseptic Full time €45,000 - €60,000

Aseptic Manufacturing Process Specialist

The role of Aseptic Manufacturing Process Specialist is pivotal in the production of sterile parenteral drugs. This position involves operating and setting up manufacturing equipment, processing parts and components, conducting transactions in electronic systems, and maintaining cleanliness and sanitation of production areas.

This job specification outlines the general responsibilities associated with the Aseptic Manufacturing Process Specialist role. Colleagues are expected to be adaptable and contribute to continuous improvement initiatives. Successful candidates will be required to work a shift pattern and possess previous aseptic experience.

Main Responsibilities:

  • Perform all operations with due care and attention, adhering to Good Manufacturing Practices (GMP) and regulatory requirements.
  • Solve problems and troubleshoot, documenting investigations as necessary.
  • Conduct self-inspection during Quality & Safety Audits within their functional area.
  • Participate in company audits with regulatory bodies.
  • Support cross-functional training for team members and champion safe working practices.
  • Identify operational improvement opportunities and process-related issues for effective resolution and implementation.

Requirements:

  • Educated to Leaving Certificate standard or equivalent, including Mathematics & English.
  • A third-level qualification in a relevant subject area is an advantage.
  • Relevant experience in operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.
  • Demonstrated knowledge of GMP principles and aseptic knowledge in GMP areas.
  • Experience working with equipment used in parenteral product manufacture.

What We Offer:

We provide a Total Rewards Plan comprising health and welfare plans, financial plans, work/life balance, and career development opportunities. This includes comprehensive employee benefits, a discretionary annual bonus program, and opportunities for professional growth and well-being.

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