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Process Engineer (Middletown, DE, US, 19709)

Datwyler Pharma USA

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million. Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a... Summary We are looking for a hands‑on and detail-oriented Process Engineer to support daily manufacturing operations and lead the execution of validation activities within our coating process. This role is responsible for both process engineering support and validation responsibilities to ensure smooth production, process improvement, and regulatory compliance. Essential Functions Providing day-to-day process engineering support to manufacturing for coating operations, troubleshooting issues and ensuring stable production processes in a 24/7 manufacturing environment. The planning, execution, and documentation validation activities for processes, equipment, and systems. Collaborating with production, quality, and maintenance teams to maintain existing and introduce new processes and equipment, including the creation of new procedures and methods of manufacturing. Analysis of process data to identify trends, root causes, and opportunities for improvement. Drive and support process optimization, continuous improvement projects, and change control activities. Ensure all validations are completed on time and in alignment with project timelines and manufacturing schedules. Follow all organizational policies, standard work instructions, and applicable safety regulations; attend required trainings and meetings. Complete assigned tasks efficiently and on time; organize work effectively, set priorities appropriately, and meet productivity standards. Promote and maintain a safe working environment by identifying and reporting potential hazards; actively support team and site safety initiatives. Demonstrate initiative and accountability; adapt to changes in tasks, team structure, or workplace needs; follow through on commitments and responsibilities. Participate in department and quality team meetings; propose and support the implementation of process improvements. Support fellow process engineers, project engineers, and operations staff in equipment design and reliability improvement efforts. Contribute to and support continuous improvement activities and initiatives across the organization. Assist in training new team members or trainees as needed. Required Education and Experience Bachelor’s degree in Chemical Engineering preferred; other engineering disciplines will be considered. 2+ years of experience in a process engineering role, ideally in a regulated manufacturing environment (pharmaceutical, medical device, chemical or biotech preferred). Strong understanding of validation principles and regulatory compliance. Strong problem-solving skills and hands‑on experience with manufacturing equipment and systems. Excellent communication and collaboration skills in a cross‑functional team environment. Experience with coating technology and clean room processing is preferred. Experience with general manual & automated manufacturing practices such as mixing, pumps & process piping, chemical dosing, and automated parts feeding & inspection systems, etc. is preferred. Exposure to Lean, Six Sigma, or other continuous improvement methodologies. Familiarity with manufacturing systems such as MES, SAP, MII, etc. Be yourself at Datwyler We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas. #J-18808-Ljbffr Datwyler

Vacancy posted 1 day ago
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