Process Engineer
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business
The Opportunity
The Process Engineer will be responsible for leading and executing Tech Transfer Activities such as Tech Transfer Protocol/Report Development, Identifying the correct equipment for different processes, verifying the compatibility of the existing equipment with the new process etc.
Role Responsibility
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Design the process following QBD (Quality by Design Principle).
- Perform lab scale batches to gather data to perform statistical analysis of the process.
- Develop process flow diagram based on the process design.
- Acquire new equipment and support their qualification activities.
- Perform process risk assessment / FMEA for different processes to understand the risk associated with the process and define mitigation steps.
- Perform pilot batches to verify the efficacy of the processes and/or for regulatory submission.
- Execute and lead process improvements projects.
- Understand the chemical properties of different raw materials and mitigate the risk associated with their interaction in the process by developing appropriate Critical Process Parameters (CPPs).
- Review production batch record to verify that the formulation record and compounding instructions matches the process design and/or pilot batch.
- Mentor and train junior MS&T engineers, fostering a culture of continuous improvement and knowledge sharing.
- Perform Out of Specification or Deviation Investigations using 6M or 5Why’s Methodology.
- Tech Transfer
- Process Design
- Process Improvement
- Risk Assessment
- Process Validation / Verification
- Pilot Batch Execution and development of compounding instruction
- Additional responsibilities as required.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:
- Bachelor’s degree in chemical engineering with minimum of 6 years related experience OR master’s degree in chemical engineering with a minimum of 4 years related experience.
- In-depth knowledge of regulatory requirements, including FDA, EMA, and other relevant authorities.
- Experience and strong knowledge of process design.
- Experience in writing and executing process validation protocols.
- Experience in performing investigations (Deviation, OOS and OOT)
- Experience and strong knowledge of various processing equipment such as mixing tank, filling machine and packaging machines.
- Experience with autoclave, incubators, filling lines, freezers, etc.
- Experience and knowledge of utilities systems (compressed air systems, vacuum systems, purified water etc.)
- Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented with strong organizational abilities.
- Highly motivated with the ability to work independently, manage multiple projects and meet deadlines.
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and competitive salary packages for financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.