A Validation Engineer is required for a global Biopharmaceutical company in Carlow. This is a state of the art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia and infectious disease. The site is less than ten years old and has been fitted with the most up to date manufacturing technology and best practices and is truly a "state-of-the-art" facility. Site activities include the development of next generation oncology products, Formulation of Vaccines & Biologics, Fill finish / Vial filling, Packaging and Global distribution.
The team on site are focussed on creating an environment where excellence, innovation, quality, compliance and teamwork support their strategy to meet the needs of their global patients.
If you want to work on the leading edge of the Biotech industry then this is the opportunity for you.
If you have 5 years directly related experience in academia, pharmaceutical or biotechnology industry and are ready for your enxt challenge, this could be the role for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
- Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.
- Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
- Implementing the requirements as outlined in the site / project Validation Master Plan.
- Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
- SME on Equipment Validation on any of; CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels
- Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
- Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Ellen Farley at LSC on 021-4777329 if you have anymore questions about this Validation Engineer opportunity!