Sterile Fill Finish Technician

2 days ago

Waterford, Ireland Morgan McKinley Full time

Job Summary

As a Manufacturing Process Technician, you will play an essential role in the sterile production of innovative treatments for Rare Disease patients. Working in a highly controlled environment, you will contribute to manufacturing processes, quality assurance, and continuous improvement initiatives, ensuring adherence to current Good Manufacturing Practices (cGMPs). Your efforts will directly support the development and delivery of life-changing therapeutics.

Key Responsibilities

Manufacturing Area Duties

- Perform all activities related to sterile manufacturing, including aseptic filling, drug substance formulation, and preparation activities.
- Execute tasks such as sterile filling, product and component reconciliation, and set-up/breakdown of single-use materials.
- Manage materials handling, weighing, dispensing, and formulation processes.
- Collect, process, store, and deliver samples as per procedural requirements.
- Conduct manual and automated cleaning of equipment and parts.
- Perform equipment and area cleaning, line clearances, and monitor clean systems, autoclaves, and processing equipment.

Documentation and Compliance

- Strictly adhere to cGMP standards and accurately complete all process-associated documentation.
- Perform calculations related to manufacturing tasks and ensure proper record-keeping.
- Identify and report malfunctions while maintaining compliance with written procedures.

Collaboration and Continuous Improvement

- Collaborate with cross-functional teams to support batch release, material processing, and audits.
- Participate in continuous improvement initiatives to optimize processes and operations.

Qualifications and Skills

Preferred Qualifications

- 3+ years of experience in a GMP or other regulated environment.
- Demonstrated knowledge and application of GMP principles.
- Experience in drug product manufacturing is advantageous.
- Proficiency in operating and understanding moderately complex equipment.
- Ability to document tasks accurately and follow detailed written procedures.

Personal Attributes

- Strong focus and attention to detail, with the ability to maintain consistency during repetitive tasks.
- Proven ability to work effectively as an individual and within a team environment.
- Coachable and open to feedback, with the capacity for measurable improvement.
- Flexibility to adapt to new challenges and evolving market demands.
- Strong communication skills, technical creativity, and a proactive approach to problem-solving.

What We Offer

Growth and Learning

- Opportunities to expand your knowledge and progress your career within a global organization.
- Access to training and development programs to enhance technical and personal skills.

Work Environment

- A diverse and inclusive culture where your ideas and contributions are valued.
- A collaborative team of innovative thinkers striving to make a meaningful impact.

Comprehensive Benefits

- Generous total rewards plan, including health, financial, and career benefits.
- Support for work-life balance and overall well-being.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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