Cache of job #14138032

Job Title

Validation Manager Msdc

Employer

MSD

Location

Carlow

Description

Would you like to join our state-of-the-art expansion project in Carlow. The opening is for a Validation Manager to join our manufacturing & commercialisation team. You will sponsor the transition of the new Carlow Expansion facility from project phase to a fully operational biologics facility. This role will focus on Cleaning Validation technical SME experience. What you will do: You will have the opportunity to be involved in the project from Site Acceptance Test (SAT) from its infancy through to the Performance Qualification. Site Acceptance Test – attendance, hands-on support and C&Q Oversight for assigned process equipment. Installation to Mechanically Complete – C&Q and Client-Side Oversight for assigned process equipment. Commissioning & Qualification – Hands-on support & Oversight for assigned process equipment. Cycle Development – Coordination & Execution of Cycle Development pre and post OQ phases for assigned process equipment. Performance Qualification – Responsibility for / Execution of Performance Qualification testing for assigned process equipment. Liaising with Tech Transfer colleagues to ensure product requirements are embedded within the project. What skills you will need: In order to excel in this role, you will more than likely have several years’ experience in academia, pharmaceutical or biotechnology industry, additionally: People Management experience is required, additionally coaching, mentoring and leading a team in the validation department in the past is desirable. A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence. Several years process equipment C&Q/ Validation experience on Large Scale Projects or commercial operations. SME on Equipment Qualification on any; CIP & Parts Washers for in-process components / Electron Beam / Vaporised Hydrogen Peroxide Isolators / Clean Utilities Transfer Panels & Formulation Vessels. Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines. Experience with sterile processing and sterilisation technologies is advantageous. Note: Role initially will be based remotely, once permitted travel to Carlow site will be required. As a company we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.  We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.  So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Date Added

1046 days ago

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