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Job Title: Validation Manager
Location: Ballytivnan in Sligo
We are seeking a Validation Manager at AbbVie to develop and maintain the validation program for AbbVie Biologics Ballytivnan (ABB), ensuring compliance with regulatory, quality, and compliance standards. The role involves active participation in validation activities and quality assurance.
Key Responsibilities:
1. Lead validation team supporting biologics validation activities.
2. Coordinate validation and qualification of equipment, utilities, processes, and software, ensuring compliance with policies and standards such as FDA, European cGMP, and GAMP.
3. Develop and execute Validation Plans, protocols, and reports adhering to cGMP.
4. Support validation investigations and implement corrective actions.
5. Manage validation documentation, change controls, and exception events.
6. Ensure validation activities are documented per cGMP.
7. Perform cross-training and onboard new team members.
8. Participate in continuous improvement initiatives.
9. Coordinate team activities and communicate with management about area operations.
10. Engage in cross-functional projects demonstrating leadership.
Qualifications:
* Degree in engineering or sciences.
* Over 3 years validation/quality experience in sterile/aseptic environments.
* At least 2 years in a leadership role.
* Minimum 3 years in a cGMP regulated setting.
* Strong knowledge of cGMP and pharmaceutical regulations.
* Excellent communication and troubleshooting skills.
* Leadership and teamwork abilities.
Why Join AbbVie?
Contribute to innovative research and enjoy growth opportunities in a collaborative environment.
Additional Information:
AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more details, visit here and here.
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