Role and Context Position Process Engineer Reporting Position Reporting to applicable Manager/Team Leader of the area Working Relationship Supporting Manufacturing areas and all support departments Key Internal Contacts: Manufacturing, QA, QC, Validation, Regulatory, EHS, Program Management and Finance Key External Contacts: Equipment vendors, component suppliers, other Genzyme sites, Development pharmaceutics groups and benchmarking organisations Purpose of Role Provide leadership and support to operations teams to ensure appropriate standards are met Development and implementation of improvement initiatives in all manufacturing and development operations Need to Do Job Requirements Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations Optimisation of manufacturing and development operations Identification & implementation of opportunities for improvements Assist in the implementation of capital projects Act as process lead for inspection development Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.Want to apply Read all the information about this position below, then hit the apply button.Implementation and monitoring of performance metrics Lead cycle time reduction initiatives in conjunction with manufacturing teams Implementation of best practice Process development programme design / plant trials, execution and implementation Constantly seeking to challenge operational standards and driving continuous improvement.Ability to multi task and prioritize workload.Maintain required quality documents in a current compliant state.Subject Matter Expert for and team resource for new product introductions / enhancement development projects Resource for Clinical supply provision projects Aseptic manufacture or oral dose manufacture context Subject Matter Expert for product quality attributes and process critical parameters Design and execution of experimental programmes Operation of process laboratories Scale-up and technology transfer project role Liaison for Clinical supply provision projects Liaison for New formulation and product enhancement programmes Technical representative for assessment and development of process change control and regulatory submission proposals Technical support and trouble-shooting in support of manufacturing activities Process/product deviation investigation and resolution Technical report writing Training delivery of technical training programmes Support of process qualification and process validation activities as required Compliance Related Tasks Complaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA's and on time closure Attainment of SMART goals.Reduction in process cycle-times.
xsokbrcEnsure compliance to c GMP at all times Need to Know Qualifications Degree in Chemical, Industrial or equivalent Engineering discipline Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage Experience 2 years + experience within Pharmaceutical Development and Manufacturing environment OEE/SMED/RCA/CI experience.