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Welcome to AbbVie!

AbbVie employees work every single day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people and, when we find them, we make it our business to treat them well.

At our site in Ballytivnan, we have expanded our facility into a multi-million-dollar state of the art biologics plant, bringing groundbreaking scientific research to real life solutions for our patients.

We are currently recruiting for a Validations Manager to join our site in Ballytivnan, Sligo. As part of your new and exciting role, you will carry out the development and maintenance of the ABB validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met.

Are you intrigued? Do you want to learn more?

A snapshot of your key responsibilities as a Validation Team Lead would be:

• Coordination / direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.
• Generation, maintenance, and execution of Project Validation Plans and schedules
• Generation of validation protocols and final reports to cGMP standards.
• QA support for validation investigations and implementation of corrective actions.
• Creation, review, and approval of various validation and qualification documents.
• Management of validation, exception event, and change control processes.
• Documenting all activities in line with cGMP requirements.
• Performing cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems
• Coordinating activities to maximize the effectiveness of all of the team members.
• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
  
  

Education and Experience:

• Bachelors/Masters degree in engineering or relevant scientific discipline
• 3 years plus validation/quality experience in sterile/aseptic environment, especially in the commissioning and qualification area
• 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
• 3 years plus of leadership experience.
• A minimum of 3 years’ experience in a cGMP regulated environment.
• Strong communication (written and oral), presentation and troubleshooting skills required
• Effective interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Capable of prioritizing work and multitasking.
• A minimum of 3 years’ experience in a cGMP regulated environment.
  
  

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 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.