Parenterals Process Scientist
Cpl are in partnership with our client Pfizer and we are currently recruiting for Process Scientists:
Role Description
This candidate will provide process science and validation support to the Parenterals syringe filling and adjuvant production operations, as well to support process tech transfer projects into site for any new products/processes that may arise. The process scientist is responsible to ensure that the process is running as intended, that it is appropriately validated and run so as to maintain that validated state.
The candidate will participate in the process monitoring and continuous process verification (CPV) programs, the process robustness program, and multiple validation programs including aseptic process simulations, shipping validation and cleaning validation.
This role may also require leading major process investigations, implementation of cost reduction projects, assisting in technology transfer execution and execution of final process validation and cleaning validation studies
The potential candidate will work within the technical services team and establish strong network partnerships across Grange Castle and Pfizer (MSAT, Pharm Sci and Co-Dev) to deliver integrated technology solutions to enable the site business objectives.
The role may entail specialisation and training in process science/engineering to meet overall site business needs for technical support e.g. Process validation, technical risk evaluation, filtration, disposables, drug product formulation, Aluminium phosphate manufacturing, syringe filling and inspection etc.
Responsibilities
- Provide technical support to the Parenterals manufacturing suite across equipment preparation, formulation, syringe filling and automated visual inspection.
- Provide technical support to the Aluminium phosphate process
- Execute cycle development and load qualification across cabinet washers and autoclaves
- Support the validation and troubleshooting of filters for the sterilization of process fluids and gases.
- Participate in the Continuous Process Verification (CPV) program in Parenterals to ensure the manufacturing processes remain in a validated state.
- Represent the Technical Services team in Process Robustness, Continuous Improvement, and cost reduction processes
- Be SME on Informa and provide digital solutions for data capture and visualization where required
- Lead major process investigations, perform root cause analysis and support the implementation of CAPAs
- Support the introduction of new materials and review Supplier Change Notifications (SCN) as required
- Lead or manage change controls for Technical Services through concept, approval at CRP and delivery of action items
- Provide subject matter expertise for significant events, regulatory submissions and audit response
- Participate in or lead technology transfers of new processes or equipment. Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions, risk assessments and flow diagrams, interacting and training with donating site personnel
Experience
1. Minimum of 3 years industrial experience in technical, quality or operations role at an aseptic GMP manufacturing facility.
2. Strong statistical background with experience working with Minitab, Informa and APQR.
3. Experience working with statistical trends across manufacturing, release or stability.
4. Demonstrate an aptitude for technical learning and problem solving.
5. Experience and knowledge of drug product formulation and/or media simulations and/or aseptic filing and/or their inspection technologies preferred.
5. Experience and knowledge of process and cleaning validation will be an advantage.
6. Knowledge of Quality requirements and Regulatory guidelines.
Education
Minimum qualification of a B.Sc. Degree in Bioprocess Science, Engineering, Biotechnology or equivalent with a preference for Biochemical, Chemical or Biological disciplines.