Job Description
We are looking for a Validation Engineer to join our Technical Operations team in Manorhamilton Road, Sligo.
This is a fixed term contract for 12 months.
This position reports to the Validations Team Lead.
The 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 coordinating the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements.
Responsibilities
Coordinate, implement and participate in the site Validation Program.
Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
Coordinate, direct 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 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 communication skills with the ability to write protocols and reports.
Proven problem‑solving skills and the ability to adapt to new regulatory requirements.
Equal Opportunity
AbbVie is an equal–opportunity employer and is committed to operating with integrity, driving innovation and transforming lives. Equal Opportunity Employer / Veterans / Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more.
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