Job Description We are looking for a Validation Engineer to join our Technical Operations team in Manorhamilton Road, Sligo.
This position reports to the Validations Team Lead.
This role provides the successful candidate with the opportunity to get exposure to a broad range of validation activities on our site.
You will be responsible for co-ordinating the development and maintenance of the company's validation program in compliance with all applicable regulatory and company requirements.
Responsibilities : Co-ordinate, implement and participate in the site Validation Program.
Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
Co-ordinate / direction and participate in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
Generate/maintain Validation Master Plans.
Generate /maintain Project Validation Plans.
Generate validation plans, write protocols and final reports to cGMP standard.
Review / approve of protocols and final reports as required.
Manage validation change control process.
Adhere to and support all EHS E standards, procedures and policies.
Qualifications 3rd level qualification in a relevant engineering or scientific discipline.
A minimum of 2 years experience in a cGMP regulated pharmaceutical manufacturing environment.
High level of attention to detail and mental concentration, to ensure accuracy and compliance.
Excellent communications skills with the ability to write protocols and reports.
Proven problem-solving skills and the ability to adapt to new regulatory requirements.
Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled.
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