Senior Process Development Engineer
Louth / Meath, Dublin North
What you need to knowYou will work as a Senior Process Development Engineer for our client, aleading pharma companyinDublin. The objective of this role is to lead and coordinate process improvement strategies for existing formulations, provide technical support as required to the Manufacturing Department, coordinate projects such as Scale-ups, Second sourcing, New Equipment Introduction, Launches, etc. This is apermanentjob. Your new jobKey duties & responsibilities: To troubleshoot existing problem formulations and suggest, implement and validate suitable improvements. To coordinate technical transfers and scale up of products from R&D/ Pilot Plant into the Manufacturing facility. To coordinate manufacturing activities for the manufacture of R&D scale up, clinical batches within the pilot plant/production facilities in support of any submission processes. To ensure the maintenance of processes and procedures and general cGMP status of the Pilot Plant at all times in line with requirements of IMP License. To lead technical Investigations where required and to write, review and approve Investigation Reports. To determine the manufacturing requirements for new products. To assist in the timely sourcing of Manufacturing equipment and tooling required for new products or as a result of process improvement initiatives. To ensure that all Process Validation systems are maintained in line with current Global Policy and current regulatory /manufacturing license requirements. To ensure timely execution of Trial and Validation batches including the writing, review and approval of validation protocols and reports. Responsible for the handling and storage of Controlled Drugs in accordance with relevant procedures, ensuring product security. Support the implementation of the Operational Excellence Programme on the site by identifying, leading and implementing improvements. To act as change agents by gaining support for and driving sustainable improvements to ways of work. To adhere to all company and legislative health, safety and environmental requirements. Any other task assigned by the Technical Development Management. What are we looking for? Honours Degree in Science or related discipline. Process Validation course and Process Development and Formulation courses would be ideal though not essential. At least 5 years’ experience within the pharmaceutical industry. Thorough knowledge ofOSD processes, process development and tablet formulation would be a distinct advantage. Apply for this job now or get in touch withJoanneon01 4690901. Matrix Recruitment Group is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent. This job originally appeared on RecruitIreland.com.
335 days ago