Validation Specialist, Dublin

WHAT WE ARE LOOKING FOR

The Validation Lead is the site authority for validation strategy to ensure that all manufacturing, utility, IT and process systems are fit for purpose, scientifically justified and compliant with regulatory expectations throughout their life cycle - from design through operation and revalidation.

YOUR ROLE

Act as Validation SME for capital projects and engineering changes from concept and design through commissioning and qualification Own the Site VMP with annual plan and periodic review of execution Ensure that CQV activities are delivered to meet expectations to the highest safety, environmental, quality, and operational & performance standards. Field execution of Commissioning, Installation & Operational Qualifications (IQ/OQ). Author, review and approval of testing protocols and summary reports. Review, approve and critically assess vendor prepared/executed commissioning & validation documentation, ensuring suitability for GMP use. Act as site SME for Cleaning Validation, define and maintain a site cleaning validation strategy including Sampling strategies, MACO based acceptance limits, CIP validation. Provide expert input during regulatory inspections and audits on validation Responsible for initiation and completion of deviations/exceptions, CAPAs, and change controls for process systems including investigations relating to equipment or process performance. Work and coordinate with cross function departments to ensure solutions are implemented in an efficient and effective manner. Own and implement the periodic review and revalidation requirements to maintain equipment and systems in a validated status. Periodic review of equipment/systems to ensure both regulatory & business needs are satisfied. Ensure that EHS roles and responsibilities are complied with as per the requirements of the site Safety Statement.

YOUR BACKGROUND

Minimum of a bachelor’s degree in B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required. Minimum 8 years’ experience within the life sciences environment. Experience in commissioning, qualification and validation activities in a GMP environment, including the generation of procedures, plans and policies. A proven identifiable track record of success in a similar environment. Good organizational skills and attention to detail. Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally. Ability to prioritize, manage multiple tasks, and meet deadlines. Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV practices. DeltaV & SAP process equipment experience advantageous.

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,  Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world, Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. or you can also call this number +19843443717