Validation Lead

2 weeks ago

Dublin, Dublin City, Ireland Guerbet Full time

​

Validation Lead   M/F (29380)

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging.

As a pioneer in the field of contrast products since the last 95 years, we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis, and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

Location: Ireland, Dublin

Role Purpose: The Validation Lead is responsible for ensuring that all manufacturing process systems perform and operate as per their design. The Validation Lead will ensure that all systems, conform to relevant regulatory requirements as well as company specifications and standards. 

Your responsibilities:

Ensure that Validation 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. Coordination of vendor packages to achieve streamlined Commissioning & Validation. Review of vendor prepared/executed commissioning & validation documentation. Responsible for initiation and completion of deviations/exceptions, CAPAs, and change controls for process systems including investigations relating to equipmentperformance.. Communicate and troubleshoot any issues arising from documentation preparation and documentation execution. Work and coordinate with cross function departments to ensure solutions are implemented in an efficient and effective manner. Act as owner and SME for all site commissioning and qualification plans and procedures. Define 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. Support internal and external audit activities pertaining to validation topics. Ensure that EHS roles and responsibilities are complied with as per the requirements of the site Safety Statement. Perform other related duties as assigned from time to time based on company needs.

Your profile:

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 Validation practices. DeltaV & SAP process equipment experience advantageous.

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

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