Company Description

AbbVie's 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 people's 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 www.abbvie.com. Follow @abbvie on X (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.

Job Description

We are currently looking for an Aseptic Trainer 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 AbbVie’s 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

• 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, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html