Sterile Manufacturing Specialist

10 hours ago


Cork, Cork, Ireland beBeeSterileManufacturing Full time €40,000 - €60,000
Role Summary

This is an exciting opportunity for a highly skilled and motivated Sterile Manufacturing Specialist to join our dynamic team. We are seeking an individual who is passionate about delivering high-quality products and committed to ensuring the highest level of safety and compliance in our manufacturing processes.

Key Responsibilities
  • Perform sterile filling operations using isolator technology, including recombination and pooling of drug substance.
  • Set up and operate filling lines, equipment and line changeovers, and perform sampling in accordance with approved procedures prior to visual inspection activities.
  • Operate the parts washer and autoclave, and perform root cause analysis of equipment and process problems, implementing effective solutions, including preventive and/or corrective actions.
  • Work closely with cross-functional teams, including Quality, Maintenance Technicians, Material Operations, Supply Chain, and others, to ensure seamless communication and collaboration.
  • Participate in continuous improvement initiatives, lead and support investigations into quality events, and provide leadership and guidance on shift to support and influence positive behavior.
  • Collaborate with external vendors and service providers as needed.
Requirements
  • Proven track record in a quality-focused, operational GMP environment.
  • Previous experience in syringe and vial sterile filling and visual inspection is highly desirable.
  • Strong mechanical aptitude and technical experience.
  • Ability to work effectively in a fast-paced environment with multiple priorities and deadlines.
  • Excellent communication and problem-solving skills, with demonstrated leadership skills preferred.
Benefits

Our company offers a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development. As a valued member of our team, you will have access to ongoing training and education, as well as a collaborative and supportive work environment.

About Us

Our organization is dedicated to advancing human health through innovative scientific research and development. We are committed to fostering a culture of excellence, innovation, and teamwork, and we seek individuals who share our values and passion for making a difference.



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