Overview
We are hiring a Sterility Assurance Lead to join our quality organisation in AbbVie Biologics, Ballytivnan in Sligo. In this key role, you will ensure that all products from our facility meet the highest standards for both marketed and investigational drug products. This is an exciting opportunity for a proactive leader to influence and shape sterility assurance and contamination control strategies at a leading biopharmaceutical site, while working cross-functionally with global and local teams.
Responsibilities
* Own and continually develop the site's Contamination Control Strategy.
* Collaborate with Operations and QC Micro Lab to design and deliver robust training programs on aseptic processing, aseptic behaviors, and principles for site staff.
* Develop, implement, and monitor gowning, cleaning, and sanitization strategies in conjunction with relevant stakeholders.
* Establish and maintain environmental monitoring and clean utilities programs.
* Serve as subject matter expert on sterility assurance during regulatory inspections, audits, and cross-functional initiatives.
* Guide the investigation of contamination-related non-conformances and events, and provide technical input to microbiological method transfers.
* Analyze and review microbiological data to identify trends and implement effective risk mitigation.
* Liaise with global Science & Technology functions to ensure site alignment with industry best practices and regulatory requirements.
* Maintain compliance with governing regulations and lead by example in promoting best contamination control practices through ongoing training and floor presence.
* Support continuous improvement initiatives, corrective action implementation, and efficient quality-operations relationships.
Qualifications
* BS in science or equivalent (Chemistry, Microbiology, or Biology preferred)
* 2-5 years of laboratory experience
* 2-5 years of supervisory experience
* Demonstrated skills to deal effectively with members of the department and the areas serviced by the laboratory
* Problem solving skills are required
* Must be able to interpret impact of laboratory data for appropriate and effective actions
* Must be able to identify problem areas requiring development, maintenance, production, engineering, accounting, or planning with assistance from more senior staff
* Must also be able to identify, communicate, and follow-through to completion and assist in the development of necessary corrective action plans to resolve the problem with supervision. May also assist in the activities required for the investigation and resolution
Additional Information
* Bachelor’s degree or higher in a relevant technical discipline (science or engineering); Microbiology qualification is desirable.
* Minimum 4-5 years’ experience in the pharmaceutical or biopharma industry within a Quality or Operations function, preferably in a GMP environment.
* At least 1 year of experience in an aseptic sterile fill-finish manufacturing environment and 1 year in a microbiological role supporting such environments.
* Proven ability to work cross-functionally and influence site teams in a highly regulated setting.
* Strong understanding of regulatory requirements related to sterility assurance and compliance.
AbbVie is committed to fostering a diverse and inclusive workplace. If you are enthusiastic about quality, compliance, and continuous improvement, we encourage you to apply and help shape the future of sterility assurance at our Ballytivnan site. For more information about AbbVie, please visit www.abbvie.com.
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.
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
#J-18808-Ljbffr