Process Engineer (System Owner)

Job Requirements

• Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations
• Optimisation of manufacturing and development operations
• Identification & implementation of opportunities for improvements
• Assist in the implementation of capital projects
• Act as process lead for inspection development
• Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.
• Implementation and monitoring of performance metrics
• Lead cycle time reduction initiatives in conjunction with manufacturing teams
• Implementation of best practice
• Process development programme design / plant trials, execution and implementation
• Constantly seeking to challenge operational standards and driving continuous improvement.
• Ability to multi task and prioritize workload.
• Maintain required quality documents in a current compliant state.
• Subject Matter Expert for and team resource for new product introductions / enhancement development projects
• Resource for Clinical supply provision projects
• Aseptic manufacture or oral dose manufacture context
• Subject Matter Expert for product quality attributes and process critical parameters
• Design and execution of experimental programmes
• Operation of process laboratories
• Scale-up and technology transfer project role
• Liaison for Clinical supply provision projects
• Liaison for New formulation and product enhancement programmes
• Technical representative for assessment and development of process change control and regulatory submission proposals
• Technical support and trouble-shooting in support of manufacturing activities
• Process/product deviation investigation and resolution
• Technical report writing
• Training delivery of technical training programmes

Support of process qualification and process validation activities as required

• Degree in Chemical, Industrial or equivalent Engineering discipline
• Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage

Experience

• 2 years + experience within Pharmaceutical Development and Manufacturing environment
• OEE/SMED/RCA/CI experience.

Skills & Knowledge

• Technical knowledge(theory and practice) of aseptic manufacturing including lyophilisation considered an advantage
• Design of Experiment and associated statistical techniques
• Pharmaceutical product development project life-cycle
• Strong report-writing and verbal communication skills
• Laboratory and pilot plant skills
• Research skills
• Innovation and creativity skills

Project management skills

• Structured Problem-solving skills – Statistical, 6s, PIAT

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.