Aseptic Operations Manager (FTC)
Aseptic Operations Manager (FTC)
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Job Description
AbbVie is a global researchbased biopharmaceutical company committed to delivering innovative solutions that make a difference in peoples lives. Our Ballytivnan site is at the forefront of biologics manufacturing and we are seeking a dynamic leader to join our team on a 12month fixedterm contract.
Join our team at AbbVie in Ballytivnan where you will play a crucial role in ensuring that all products meet the highest standards for marketed and/or investigational drug products.
As an Aseptics Operations Manager you will be instrumental in maintaining our sites Contamination Control Strategy and driving excellence in aseptic processing and sterility assurance.
Key Responsibilities:
- Own and manage the sites Contamination Control Strategy.
- Develop and implement a training program for aseptic processing in collaboration with the operations group.
- Conduct training on aseptic behaviors and principles for the ABB site.
- Establish clean utilities and environmental monitoring programs in partnership with the QC Micro Lab.
- Collaborate with operations to develop site strategies for gowning cleaning and sanitization.
- Monitor and interpret microbiological data to identify trends.
- Liaise with global S&T to ensure sterility assurance best practices are followed.
- Provide technical assistance for contaminationrelated nonconformances or events.
- Ensure compliance with sterility assurance regulations.
- Support the transfer of microbiological test methods to the site.
- Act as the sites Subject Matter Expert (SME) for aseptic operations during regulatory inspections.
- Perform additional duties as assigned.
Qualifications :
- Bachelors degree in a relevant technical discipline (science/engineering). A Microbiology qualification is desirable.
- Minimum of 5 years experience in a Quality/Operations role in the pharmaceutical or biopharma industry.
- At least 1 year of experience in an aseptic sterile fill finish manufacturing environment.
- At least 1 year of experience in a microbiological function within an aseptic sterile fill finish facility.
- Proven ability to work crossfunctionally.
Skills and Experience:
- Strong technical and business knowledge in a GMP environment particularly in pharma/biologics.
- Thorough understanding of regulatory requirements.
- High attention to detail and a strong commitment to quality.
- Proven problemsolving skills and the ability to think innovatively.
- Excellent communication and interpersonal skills.
- Demonstrated leadership and ability to influence crossfunctional teams.
Additional Information :
Interested candidates should submit their resume and cover letter outlining how their experience meets the qualifications of the Aseptics Operations Manager role.
Join AbbVie today and contribute to our mission of delivering highquality lifechanging therapies to patients worldwide.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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No
Employment Type :
Fulltime
Employment Type
Full-time
