Process development engineer [h1.location_city]
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Process development engineer • pomona ca
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DechraPomona, CA, United States[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Design, develop, and optimize pharmaceutical manufacturing processes, ensuring compliance with cGMP (current Good Manufacturing Practice) and regulatory requirements. Lead process improvements to enhance product quality, reduce costs, and increase efficiency. Perform lab scale batches to gather data to perform statistical analysis of the process using a statistical tool such as Minitab or Jump. Provide technical expertise in the scaling up of processes from development to commercial production. Perform process troubleshooting, data analysis, and root cause investigation for any operational issues. Collaborate with R&D, production, and quality teams to transfer new products into manufacturing, ensuring smooth process validation and process characterization. Design and implement experiments to optimize critical process parameters. Perform process risk assessment / FMEA for different processes to understand the risk associated with the process and define mitigation steps. Develop and manage process documentation, including Standard Operating Procedures (SOPs), batch records, and process control documents. Lead and participate in process validation activities, including protocol development, execution, and reporting. Mentor and guide junior engineers and technicians, providing training on process engineering principles and techniques. Work with regulatory bodies and ensure all processes meet required standards for FDA, EMA, and other international agencies. Maintain a strong focus on safety, quality, and cost-effectiveness in all process engineering activities. Bachelor’s degree in chemical engineering, Pharmaceutical Engineering, Manufacturing Engineering or a related field (master’s degree preferred). Minimum of 5 years of experience in process engineering, preferably in the pharmaceutical or biotech industry. Strong understanding of pharmaceutical manufacturing processes, equipment, and technologies (e.g., production, formulation, filling, packaging). Experience with process optimization, scale-up, and validation techniques. In-depth knowledge of cGMP, FDA, and EMA regulations. Strong problem-solving skills, with the ability to perform root cause analysis and implement corrective actions. Excellent communication and project management skills. Ability to work independently and as part of a multidisciplinary team. Experience in writing and executing process validation protocols. 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. Experience with Lean Manufacturing and Six Sigma methodologies. Experience with process modeling software or other process simulation tools. Experience with Statistical Software such as Minitab or Jump. Knowledge of automation systems and digitalization in pharmaceutical manufacturing.
Vacancies
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.
- No Third-Party Agencies, Please
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including :
Ensure seamless communication between departments, ensuring that engineering solutions are aligned with production and regulatory needs.
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 :
Preferred Skills :
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.
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