- Location: Waterford
- Shift: Days role
- FTC
About the Opportunity
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
The Process Engineer works in the MSAT/Technical Services department as a technical leader providing support to technology transfers and Commercial Operations at the Waterford Facility and within the network.
Key Responsibilities:
- Provide leadership and support to operations teams to ensure appropriate standards are met
- Development and implementation of improvement initiatives in all manufacturing and development operations
- 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
- Complaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA’s and on time closure
- Attainment of SMART goals.
- Reduction in process cycle-times
- Ensure compliance to cGMP at all times
About You
- 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
- 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
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Top Skills
What We Do
We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.
Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
.png)
