Process Technologist

Production Technologist/Senior Process Operator

About the Opportunity

Be a key member of the APT, including attendance at daily + QDCI meetings reporting on performance against an agreed schedule. Promote new ways of working and strive for continuous improvements within APT activities. Play a significant role in the APT with far reaching impact on the business.

About Sanofi Business Unit

The CDMO facility and supporting critical utilities perform investigational, optimisation and manufacturing of Active Pharmaceutical Ingredients (API's) and Drug Products for clinical trials or commercial use. CDMO may encompass initial research or development work at scale, through clinical trials material manufacturing to commercial supply.

Key responsibilities

• Has an understanding of cGMP and relevant regulations related to the function and APU.
• Empowered to make decisions for the function with the interest of the APT considered at all times. Escalate appropriately outside of area of responsibility.
• Operate the K1 CDMO facility and supporting critical utilities (the area), including executing commissioning, qualification, manufacturing and cleaning documentation in an efficient, safe and compliant manner.
• Maintain levels of training in a compliant and up to date manner. Support and contribute to cross-skilling and training within the APT.
• Be a strong, positive and influential member of the APT, actively contributing to the success of the team.
• Acts as a source of technical expertise for others within the APU and represents the department to other functions and employees outside of the APU as required.
• Contributes to production assessment of new products to be tech transferred to the facility and contribute to development of product introduction planning.
• Contributes to generation of DoE assessments and planning as required to support new product introductions as part of the tech transfer process.
• Responsible for maintaining the facility and supporting critical utilities in state of business readiness.
• Drives standards for both HSE and GMP and leads by example.
• Actively participates in regular managerial safety visits (or similar) in the area and maintains a high level of HSE vigilance at all times.
• Actively participates in regular quality visits (or similar) in the area and maintains a high level of quality vigilance at all times.
• Actively participates in regular SMS visits (or similar) in the area and maintains a high level of SMS compliance at all times.
• Contributes to the update of all necessary procedural quality documentation to ensure ongoing compliance.
• Completes assigned HSE or quality actions in the area in a timely manner.
• Actively participates in the project team meetings for each programme or new product introduction under investigation and actively contributes to the facility readiness elements of the project.
• Actively participates in compliance audits (e.g. HSE / quality) in the area.

About You

To excel in this role you will need to have:

Essential requirements:

• Experience in the pharmaceutical or related industry.
• Experience of working and managing in a 'pilot scale' environment, including for development, clinical material supply or commercial manufacturing.

It would be advantageous to have (not essential):

• Experience of working and managing in a clean room environment.
• Knowledge and experience of lean principles.
• Proven track record of problem solving.
• Effective written communication skills.

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