Oxford Global Resources is looking for a Technical Operations-Person in Plant (Filling Engineer) who will join an exciting and amazing Covid 19 Tech Transfer 14 month project. Our client one of the TOP Pharmaceutical companies is working together with a CMO located in France (close to Lyon) in the Covid Fill Finish Manufacturing process. TO-PiP will definitely be a key person in between both organizations and will oversee the activities of the plant operations being a confirmed project for the next 14 months.
Job Description
The TO-PiP will definitely be a key person in between both organizations and will oversee the activities of the plant operations. The Person in Plant will work together with the TLI (Technical Launch Integrator) and will act as the Single point of contact for the project team pertaining to plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management) including launch support.
Responsibilities
- Sample handling
- Technical and manufacturing integration of the products into the supply chain.
- Supply Chain technical input and technical acceptance of the product into the supply chain including metrics through a process of "touch points", thereby ensuring "one voice of the customer" across projects and across plant.
- Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of technical expertise (e.g., platforms, engineering, SME's) into project execution and technical implementation at the manufacturing site level.
Requirements
- Bachelor's degree in Chemistry, Chemistry Engineering, Industrial Pharmacy.
- Fluent in French as well as English (speaking and writing).
- Good communication and interpersonal skills.
- Several years hands on experience in aseptic fill finish, parenteral product, in operations environment.
- Familiar with batch records and BR review, deviation handling, relevant GMP systems.
- Hands on experience with compounding, fill finish, visual inspection and (pref) also packaging equipment.
- Experience in sample management / handling
- Experience with Tech transfer projects
- Flexibility to work evenings and weekends -if needed-
