Job Title:
Upstream Process Engineer
Job Description
We are seeking a highly skilled Upstream Process Engineer to join our team. As an Upstream Process Engineer, you will be responsible for providing technical support on the upstream manufacturing process for a Process Area Project. Key responsibilities include liaising with the engineering/automation design team in relation to the design, qualification and startup of the upstream manufacturing process.
You will also help structure detailed process designs to support the build of the new DCS system Delta V. Defining the structure of the integration of both the DCS and MES system is another critical task. Supporting the designing of new DCS bioreactor recipes to integrate with Delta V is also an important part of this role.
As an equipment/process SME for HAZOP sessions, you will support the safe design of the plan. Supporting FAT and SAT for both equipment and automation is also a key responsibility. You will also support the safe start up and commissioning of the new process equipment.
Owning the qualification of small equipment for the new process area is another critical task. Managing GMP area release of the production area is also a key responsibility.
Providing technical input into electronic MBR's, batch sheets and procedures is also an important part of this role. Writing & reviewing new electronic Standard Operating Procedures or other controlled documents for the newly automated process area is also a key responsibility.
Communicating with project team regarding changes to the process or material used within the process is also a key responsibility. Working with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control is also an important part of this role.
This role requires 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 is also a key responsibility.
Supporting investigations into process variances according to site procedures is also a key responsibility. This role may be suitable for you if you have strong Upstream Process knowledge or experience as a SME with Upstream Processing.
You should have deep Technical knowledge cGMP manufacturing and the ability to maintain integrity and honesty at all times. Strong project management experience and the ability to balance multiple projects, prioritise them and execute them thoughtfully and independently are also required.
To be considered for this position, you must hold a BS/BA/BEng or higher with Life Sciences or other related discipline. For Specialist level, you must have 3+ years practical experience working in Upstream Process area. For Sr Specialist, you must have 5+ years practical experience working in Upstream Process area.
],