The Pharmaceutical Technology Specialist will be responsible for coordinating and executing technology transfer activities in a state of the art pharma facility. The Pharmaceutical Technology Specialist III provides high level troubleshooting of existing and new processes, generates batch manufacturing records and standard operating procedures for all new technologies.
- Serve as site representative on technical transfer project teams, ensuring that production concerns and recommendations are factored into early stage product development in order to optimize manufacturing processes and ensure the site’s ability to consistently supply the new product in the production environment.
- Lead on-site new product development projects to meet the facility strategic objectives, including coordinating project activities across all relevant functions and internal and external resources and monitoring and reporting project status.
- Execute the validation strategy for each new product being transferred or existing product being enhanced, including providing recommendations for batch sizes against forecast and performing and maintaining risk assessments.
- Prepare and execute feasibility, NDA, pre-validation and validation protocols and reports that enable first time right execution of manufacturing process.
- Follow the Corporate Tech Transfer guideline and ensure that the knowledge milestones are executed and documented thoroughly.
- You will develop new Standard Operating Procedures for new technology and make recommendations for continual improvement of the GMP procedural documentation (BMR’s, SAP PI Sheet, SOP’s, Forms).
- Provide on-going technical analysis and support on newly transferred and existing products, including process optimisation, lifecycle management, batch scaling and timely troubleshooting, performing root cause analyses and recommending preventative actions.
- Provide technical support during the implementation of new process technologies, including Qualification, FAT, IQ, OQ, and coordinate PQ and process validation.
- Educate site personnel on new technologies being introduced as part of the NPI program and develop training materials and programs for new and existing process technology or procedural changes.
- Carry out and assist in the on-going training of new and existing personnel, as appropriate.
You should have third level qualification in Chemistry or related Science with at least 2 years related experience and/or training; or equivalent combination of education and experience.
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.