Orion Group Life Sciences are looking for a Validation Lead on behalf of our Multinational Pharmaceutical/Biotechnology client located in Dublin, Dun Laoghaire. Initial 12-month contract, with possibility of extension. This is a hybrid role, where you have to be at least 3 days onsite. What will you do: Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.Key contributor to product and process investigations, responsible for assessing product and process impact.Leads continuous improvement projects to improve process performance and productivity.Assess product impact associated with proposed changes to commercial processes under the change control process.Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.Review and approve changes to operating procedures, electronic batch records, and product documentation.Identifies and implements operational opportunities for current and new sterile operations.Risk assessments and mitigation projects relating to line performance.Perform process gap analysis and developing strategies to close gaps.Data trend analysis for all performance aspects of the area.Troubleshooting performance trends.Requirements and Skills: Bachelor's or Master's degree in Engineering, Science or related discipline with 6 years' experience in a similar role OR PhD and 3 years of directly related experience.Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.Typically, 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling, lyophilization or process design or NPI.Qualification in Lean and 6-sigma methodologies would be an advantage.New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, ****** or contact Tim on 0044 7593448607.
#J-18808-Ljbffr
