Role:- Technical Leader (Med Device/pharma) Location:- North Yorkshire
Type:- 18 month FTC
Benefits:- 5% bonus, BUPA Private Medical Insurance ,25 days holiday + 8 bank holiday, Pension max 8%, 4 x Salary death in service, canteen, gym
Russell-Taylor Group have a fantastic opportunity to join a massively growing Medical Device company. Our client is looking for someone who can demonstrate an appropriate level of knowledge, ability, and experience particularly in project management, technical assessments, scientific methodology and process/equipment validation. They will ideally come from a Medical Device background, but other regulated industries will also be considered.
- Working on Asset transfer project of moving the production facility to North Yorkshire.
- Managing of small projects at one time and progressing raw material changes (e.g.- strategy for qualification, trial and selecting of alternatives, running the process trials)
- Dedicated to the project and understand the products and processes. Will be primarily dedicated to delivering the process qualification work stream under the supervision of the technical manager. This will include writing process qualification protocols, arranging analytical testing, data reporting and writing reports for each product section.
- Responsible and contribute to strategic planning & delivery of elements for the scientific work-streams. These steams include;
- Performance qualifications for mixing, coating, conversion, and packaging processes on new and transferred equipment.
- R&D Laboratory, test equipment & test method relocation
- Stability programme, facility and test methodology move.
- Respond to any customer technical questions regarding impact of the move on their products, product design & product safety.
- Provide technical reports, rationales & supporting documentation as well as relocating R&D design files & records.
- Work in line with industry standards, to site QMS, and consider customer requirements by liaising with them to facilitate any necessary change and updates on progress.
- Propose solutions to logistical and technical problems.
- Work closely with the existing technical team and various other teams.
- Issuing technical report and justifications
- A scientific degree or equivalent with a science or engineering background.
- Minimum of 2 years' experience in the Medical Device field, or alternative regulated industry
- Previous experience in project management, technical assessments, scientific methodology and process validation
- Process Excellence qualification or training or even knowledge in this area (desirable)
- Ideally looking for someone with an understanding of ISO 10993, biological end point testing and experience of consulting product safety assessments with respect to material changes(desirable)
- Experience of providing technical reports.
- Ability to project manage and work within a fast-paced environment.