Process Engineer

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...

The Process Engineer will lead the washing to ensure products meet regulatory requirements and on-time customer delivery. This position will be responsible for cycle development, applying and introducing best practices. Create and apply a re-qualification program and validation master plan that meet regulatory requirements. A diverse knowledge of washing and water systems, equipment, control methods, techniques and documentation are key skills for this position.

The Process Engineer will cover 2 sites located in Pennsauken, NJ and Middletown, DE.

• Creates and assists with the execution of User Requirement for the process. This includes the creation and review of validation, verification documents and procedures related to the respective process.
• Manages the validation of new designs, re-qualification practices, bracketing approach to cycle development and process improvements. Will address cycle failures by developing short-term and long-term plans to prevent recurring issues. Reviews and recommends new or enhanced procedures and/or processes to maximize efficiency and to continuously improve the process and the quality of products produced
• Analyses of test data against established protocols and develops validation strategies to address anomalies or deviations. The Process Engineer manages all aspects of the process which includes defining preventative maintenance and calibration scheduling where required.
• Collaborates and trains on new procedures, and addresses concerns related to instructions.
• Provides day-to-day process engineering support to manufacturing operations, troubleshooting issues and ensuring stable production processes in a 24/7 manufacturing environment.
• Plans, executes and documents validation activities for processes, equipment, and systems.
• Collaborates 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.
• Drives and supports process optimization, continuous improvement projects, and change control activities.
• Ensures all validations are completed on time and in alignment with project timelines and manufacturing schedules.
• Follows all organizational policies, standard work instructions, and applicable safety regulations; attend required trainings and meetings.
• Completes assigned tasks efficiently and on time; organize work effectively, set priorities appropriately, and meet productivity standards.
• Promotes and maintains a safe working environment by identifying and reporting potential hazards; actively support team and site safety initiatives.
• Demonstrates initiative and accountability; adapts to changes in tasks, team structure, or workplace needs; follows through on commitments and responsibilities.
• Participates in department and…