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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Sterility Assurance Lead

Primary Sligo, Ireland Req ID 2302590 Category Quality Assurance Division AbbVie

Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset.   From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives worldwide. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.

We are now recruiting a Sterility Assurance Lead to join our team in Ballytivnan, Sligo, on a 1 year fixed term contract basis. As our new Sterility Assurance Lead, you will act as SME for sterility assurance joining a talented and diverse team playing a key role in ensuring that all products leaving AbbVie Biologics meet the standards required for marketed and investigational drug product.

Is this a team you want to be part of? Then read on……

Key Responsibilities:

  • Take ownership of the site's Contamination Control Strategy
  • Work closely with the operations group to develop a training program for aseptic processing
  • Provide training in aseptic behaviours and principles to the site
  • Partner with the QC Micro Lab to develop the clean utilities and environmental monitoring program for the site
  • Supervise team of Laboratory Technicians and Lab. Coordinators, scheduling their work,  vacations, and holidays. Planning & coordinating analysis of products, raw material, in-process samples, final bulk and final product samples, and water samples
  • Establish, in conjunction with the operations function, the sites gowning strategy and cleaning and sanitization program
  • Monitor and review microbiological data to detect trends
  • Liaise with the global science and technology team to ensure best practices are in place concerning sterility assurance
  • Provide technical guidance on any contamination related to non-conformances or events.
  • Ensure that the site is operating under governing regulations for sterility assurance
  • Collaborate with cross-functional teams for the transfer of microbiological test methods to the site
  • Maintain and develop site practices for contamination control etc. utilizing training and a purposeful presence on the operations floor
  • Influence operations area owners to ensure that quality issues are identified, and appropriate corrective actions are implemented to maintain compliance
  • Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
  • Adhere to and follows all procedures, policies, and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines

So what do you need for this role?

Education & Technical Skills

  • Third level qualification to degree level in a relevant technical discipline, ideally microbiology, science/engineering.
  • 3 years supervision experience in Laboratory areas
  • Minimum 5 years’ experience in the pharmaceutical industry or biopharma industry in a Quality/Operations role
  • Minimum 1 years’ experience in an aseptic sterile fill-finish manufacturing environment
  • Basic knowledge of governmental regulations and pharmaceutical compendia (USP, EP, BP, etc.)
  • Excellent verbal and written communication skills in English
  • Good statistical and scientific knowledge. These include laboratory troubleshooting and problem solving skills. Know and/or understand monitoring methods
  • Proven ability to work cross-functionally.
  • Strong knowledge of regulatory requirements is required.

So, does this all sound like the right role for you? Apply Today!

AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

Travel: No

Job Type: Experienced

Schedule: Full-time

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