Job Description We are now hiring a CSV Engineer to join our team in Ballytivnan, Sligo.
This person will be responsible to develop and execute validation protocols for computer systems and software applications, working in a cross functional team within our Biologics facility.
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
Perform risk assessments to identify critical system functionalities.
Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.
Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.
Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.
Qualification of laboratory analytical instruments Qualification of computer systems (e.g OSI Pi, POMS etc.)
Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
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 computer science, engineering or scientific discipline Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
5+ Years experience in computer system 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.
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