Job Title: Upstream Process Specialist
As a key member of our team, you will be responsible for providing technical support on the upstream manufacturing process. This includes liaising with the engineering/automation design team in relation to the design, qualification and startup of the upstream manufacturing process.
Key Responsibilities:
* Liaise with the engineering/automation design team in relation to the design, qualification and startup of the upstream manufacturing process.
* Help structure detailed process designs to support the build of the new DCS system Delta V.
* Define the structure of the integration of both the DCS and MES system.
* Support the designing of new DCS bioreactor recipes to integrate with Delta V.
* Act as an equipment/process SME for HAZOP sessions to support the safe design of the plan.
* Support FAT and SAT for both equipment and automation.
* Support the safe start up and commissioning of the new process equipment.
* Owning the qualification of small equipment for the new process area.
* Managing GMP area release of the production area.
* Providing technical input into electronic MBR's, batch sheets and procedures.
* Writing & reviewing new electronic Standard Operating Procedures or other controlled documents for the newly automated process area.
* Communicating with project team regarding changes to the process or material used within the process.
* Working with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
* Working to the highest safety standards and supporting safety implementations from the design process.
* Supporting all aspects of the upstream manufacturing process according to approved protocols, regulation, and schedule.
* Supporting investigations into process variances according to site procedures.