Senior MS&T Specialist
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Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
Job Profile Title: Senior MS&T Specialist
Direct Report To: CMO Technical Lead
Group/ Division: PSG
Career Band: Band 6
Career Track: Professional
Position Location: Swindon
Number of Direct Reports: 2
Position Summary
Lead technical subjects and small to medium scale projects and work with client SMEs in Swindon ensuring flawless execution by sharing process expertise.
Responsibilities
- Leading and managing process technologists to support technical transfer projects for both internal and client project teams to successfully implement project achievements.
- Functioning as the principal technical contact for the client alongside the Business Manager throughout the Technology Transfer and commercial phases.
- Leading process improvement initiatives and projects.
- Help present business capability for Technology Transfer to new clients by defining process and scope for new projects or bidding.
- Maintaining the point of contact with the client on technical issues and coordinating any internal responses with the relevant resources.
- Generating and approving process documentation.
- Supporting the implementation and delivery of effective safe and compliant production manufacturing operations within the agreed organisational framework.
- Ensuring the process for products to be manufactured is set up and maintained in accordance with GMP Standard Operating Procedures and other regulatory agency requirements.
- Acquiring and maintaining a bronze license Badge Production areas (Grade C/D) access and maintaining the Bronze license through successful requalification every two years.
- Implementing staff training and development programmes to assure proficiency and support the achievement of objectives.
- Participating in the equipment and process setup and validation stages through to regular commercial production.
- Understanding emergency procedures and aligning with safe systems of work. Ensuring compliance with environment health and safety rules signage and ensuring timely reporting and investigation of all accidents near misses and breaches of rules.
Qualifications/Experience
- Science or Engineering based degree ideally in Pharmaceutical or Chemical Engineering.
- Understanding of the end-to-end manufacturing filling and inspection of aseptic processes (liquids powders and lyophilisation) is important.
- Skills or proven understanding of mechanical and software operation are desirable.
- Pragmatic / common-sense approach to problem-solving.
- Demonstrable ability to make sound risk-based decisions.
- Experience in technical writing production documents such as DRs Protocols SOPs and BMRs.
- Strong project management background within for example production engineering validation or quality!
- Client-facing experience preferred.
- Skill in motivating conveying information and guiding diverse teams to meet project timelines. The position may necessitate traveling and working abroad for about two-week periods to aid in equipment validation and process setup.
Required Experience:
Senior IC
Key Skills
- Computer Hardware
- Mac Os
- Manufacturing & Controls
- Root cause Analysis
- Windows
- Customer Support
- Remote Access Software
- Operating Systems
- Encryption
- Remedy
- Chemistry
- Cerner
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
