Job Description We are now hiring a Validation Engineer to join our team in Ballytivnan Sligo.
This person will be responsible for Validation for the site and will work with the cross functional teams to ensure that all activities meet regulatory requirements.
Ensuring all validation activities on site relating to Facility, Equipment and Processes are completed in a compliant and timely matter.
Comply with Site Validation Master Plan.
Generate validation protocols for new and existing facilities, equipment and processes and review/approve all reports.
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
Perform equipment requalification activities, including Autoclave, Parts Washer, Vial Washer, Depyrogenation Tunnel, VHP and SIP cycles.
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
Initial and support validation investigations and change controls as required.
To undertake tasks and to manage specific or ad hoc projects as and when required to meet business needs.
To coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met.
Generation/maintenance/execution of the Site Validation Master Plan.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Completing all required training before executing a task.
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.
Maintaining the overall cGMP compliance of the production areas.
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 experience in validation within a regulated industry, preferably pharmaceuticals or biotechnology.
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.
Additional Information AbbVie is an equal opportunity employer and 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.
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