Manufacturing Technology Scientist
Our client has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Dublin, approximately a $1 billion investment. Once commissioned, the new facility will significantly increase their biologics manufacturing capacity and play a central role in its global manufacturing network.
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Multi Product Cell Culture facility
- Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings
- Strong knowledge of cGMP compliance, corporate, site and regulatory agency requirements.
- Assists in evaluating process performance by comparing manufacturing data to historical data from other sites
- Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the site
- Minimum BSc or equivalent with at least 4 years’ experience in cell culture or purification manufacturing technical support in the biopharmaceutical industry including experience with process validation
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills
- Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams
- You have proven problem solving ability, project management skills, including leading cross functional teams and balancing multiple project assignments
Deskstop Support Specialist required to work on large scale new build Biologics facility. This is an excellent opportunity to join this state-of-the art new build Dublin based project. You wi
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