Process Engineer

Datwyler Group; Town of Middletown (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Datwyler Group is seeking a Process Engineer to lead washing processes, develop validation strategies, and ensure regulatory compliance across two sites. You will collaborate with manufacturing, quality, and maintenance to optimize processes and deliver quality products.

You will apply best practices, manage validation documentation, and support continuous improvement initiatives in a 24/7 manufacturing environment.

Qualifications

• Bachelor's degree in Chemical, Mechanical, Biomedical, or related engineering field.
• 5+ years of experience in a process engineering role in regulated manufacturing (pharma/medical device preferred).
• Knowledgeable about washing processes and high-purity water systems; understands USP requirements.

Responsibilities

• Lead validation activities for processes, equipment, and systems.
• Develop and implement validation Master Plan and re-qualification strategies.
• Analyze process data to identify trends and root causes; drive continuous improvement.

Skills

Washing processes

Validation principles

Regulatory compliance

Cross-functional collaboration

Effective communication

Education

Bachelor's degree in Chemical, Mechanical, Biomedical or related engineering

Job description

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

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.

Essential Functions

• 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 quality team meetings; proposes and supports the implementation of process improvements.
• Supports fellow process engineers, project engineers, and operations staff in equipment design and reliability improvement efforts.
• Contributes to and supports continuous improvement activities and initiatives across the organization.
• Assists in training new team members or trainees as needed.

Requirements

• A Bachelor's degree in Chemical, Mechanical, Biomedical, or a related engineering discipline
• Knowledgeable about washing processes
• Effective communication skills both verbal and written
• 5+ years of experience in a process engineering role, ideally in a regulated manufacturing environment (pharmaceutical, medical device, chemical or biotech under cGMP preferred).
• Working knowledge of high-purity water systems (PW, WFI, clean steam) and the USP requirements behind them
• 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 washing primary packaging components (stoppers, plungers, seals) or other parts for parenteral use is a plus
• Familiarity with endotoxin and particulate test methods is a plus
• Experience with 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.
• Willingness to travel up to 25%, beyond the two sites, including customer visits, other Datwyler sites, training, and equipment vendors for FATs

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.

www.datwyler.com