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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 recruiting a Validation Engineer to join our site on Manorhamilton Road, Sligo. As our next Validation Engineer, coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met.

You will get the opportunity to coordinate, implement and actively participate in the site Validation Program and general Technical Operations activities.

Are you intrigued? Do you want to learn more?

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

• Coordination / direction and active participation in the validation of site Facility, equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.

• Generation/maintenance/execution of the Site Validation Master Plan, Project Validation Plans and schedules

• Generation of validation protocols and final reports to cGMP standards.

• Generation of validation investigations and implementation of corrective actions.

• Creation, review and approval of various quality documents and test data.

• Management of validation exception events and change control processes.

• Maintenance and tracking of validation equipment, if applicable.

• 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.

• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Qualifications

• Qualification and/or degree in engineering or scientific discipline.

• 3 years plus validation experience in pharmaceutical, diagnostics or medical device industry

• 3 years plus of knowledge of cGMP and regulatory requirements relating to pharmaceutical, diagnostics or medical device industry.

• Strong communication (written and oral), presentation and troubleshooting skills required

• Effective interpersonal and organizational skills

Additional Information

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.