Aseptic Manufacturing Specialist
Aseptic Manufacturing Specialist
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Job Description
Aseptic Manufacturing Specialist
AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas immunology oncology neuroscience and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie please visit us at . Follow @abbvie on X Facebook Instagram YouTube and LinkedIn.
Job Description
We are currently looking for an Aseptic Manufacturing Specialist to join our team in AbbVie Ballytivnan Sligo. This person will be responsible for defining and updating procedures for the site in relation to gowning aseptic behaviours and contamination control strategy. This person will be an SME in sterility assurance microbiological environmental monitoring and contamination control topics and has the opportunity to have a positive impact on our growing site in Sligo.
- Implement an effective and robust training and requalification program for isolator activities Grade C and Grade D gowning and aseptic behaviours on site.
- Provide governance and support for sanitisation programs on site.
- Support the facilities sterility assurance program and microbiological support activities to ensure the facility design equipment and filling process met aseptic requirements from design to end user.
- Represent AbbVie Ballytivnan in aseptic governance for projects to ensure all requirements for aseptic processing facility design and filling of sterile product are met as per regulatory and global requirements.
- Support the EM and utilities program process aseptic programme and contamination control strategy in a multiproduct facility.
- Understand Regulations and business processes required to maintain AbbVies and cGMP requirements for sterile product inclusive of facility design cross contamination controls and Data Integrity.
- Define and update procedures for site relative to gowning aseptic behaviours and contamination control strategy.
- Carry out training as per training plan to support facility sterility assurance program.
- Adheres to and supports all EHS & E standards procedures and policies. EHS Responsibilities.
- Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
- Continually be conscious of your own safety and that of others always complying with safety notices and barriers.
- Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve.
- Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve.
- Wearing of PPE as required.
Qualifications :
Qualifications
- A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.
- 3 5 years (minimum) experience in microbiology is a requirement & working in a sterile/aseptic/pharma environment is a distinct advantage.
- Experience in supporting regulatory inspections HPRA FDA etc is an advantage
- Bachelor Degree qualification in biology or microbiology
Additional Information :
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
