Are you a Process Engineer with 5+ years experience in drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation?This is a contract role based in Dun Laoghaire, Dublin.If you have the relevant experience, please forward your CV to ****** for review or call 353-1-7978720 to discuss in confidence.Process Engineer/Scientist - Biotech Plant - DublinJob Description Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.Process Engineer/Scientist required to work within the Process Development Commercial Support team based in Amgen Dun Laoghaire (ADL).
The team is responsible for providing process and product support to drug product formulation and fill-finish operations in ADL as drug product process SMEsKey responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following:1.
Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.2.
Key contributor to product and process investigations, responsible for assessing product and process impact.3.
Leads continuous improvement projects to improve process performance and productivity.The chosen candidate would typically be involved in activities such as (but not exclusively);• 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.• 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.The chosen candidate will work in a collaborative manner within the process teams structure and contribute as a member of cross functional teams within the local organization and functional team globally.RequirementsBachelor's or Masters 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.Preferred Qualifications:Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisationQualification 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.PackageContract roleHourly Rate €50 - €60 per hourMinimum 12 month contract
