Process Engineer

Datwyler•Middletown, DE

About The Position

The Process Engineer leads washing operations to ensure products meet regulatory requirements and are delivered to customers on time. The role covers two sites in Pennsauken, New Jersey, and Middletown, Delaware, and is responsible for washing cycle development, introducing best practices, and establishing a re-qualification program and validation master plan that meet regulatory requirements. The position requires knowledge of washing and water systems, equipment, control methods, techniques, and documentation. The Process Engineer provides day-to-day engineering support to manufacturing operations in a 24/7 production environment. The role plans, executes, and documents validation activities for processes, equipment, and systems; supports stable production; troubleshoots issues; and collaborates with production, quality, and maintenance teams to maintain and introduce processes and equipment. It also analyzes process and test data, addresses deviations and cycle failures, supports process optimization and change control, and helps ensure validations are completed in line with project and manufacturing schedules. The position follows organizational policies, work instructions, and safety regulations; supports a safe working environment; participates in quality and department meetings; contributes to continuous improvement; supports equipment design and reliability efforts; and assists with training as needed. Travel of up to 25% is required, including to customers, other Datwyler sites, training, and equipment vendors for factory acceptance tests.

Requirements

Bachelor’s degree in Chemical, Mechanical, Biomedical, or a related engineering discipline.
Knowledge of washing processes.
Effective verbal and written communication skills.
At least 5 years of experience in a process engineering role.
Working knowledge of high-purity water systems, including PW, WFI, and clean steam, and the related USP requirements.
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.
Willingness to travel up to 25%, beyond the two assigned sites.

Nice To Haves

Experience in a regulated manufacturing environment, ideally pharmaceutical, medical device, chemical, or biotech under cGMP.
Experience washing primary packaging components such as stoppers, plungers, or seals, or other parts for parenteral use.
Familiarity with endotoxin and particulate test methods.
Experience with clean-room processing.
Experience with manual and automated manufacturing practices such as mixing, pumps and process piping, chemical dosing, and automated parts feeding and inspection systems.
Exposure to Lean, Six Sigma, or other continuous improvement methodologies.
Familiarity with manufacturing systems such as MES, SAP, or MII.

Responsibilities

Create and assist with execution of process user requirements, including creating and reviewing validation and verification documents and procedures.
Manage validation of new designs, re-qualification practices, bracketing approaches to cycle development, and process improvements.
Develop short- and long-term plans to address cycle failures and prevent recurring issues.
Review and recommend procedures or process enhancements to improve efficiency, product quality, and continuous improvement.
Analyze test data against established protocols and develop validation strategies to address anomalies or deviations.
Manage process activities, including defining preventive maintenance and calibration schedules where required.
Collaborate on and train others in new procedures, and address concerns related to instructions.
Provide day-to-day process engineering support to manufacturing operations, troubleshoot issues, and maintain stable production in a 24/7 manufacturing environment.
Plan, execute, and document validation activities for processes, equipment, and systems.
Collaborate with production, quality, and maintenance teams to maintain existing processes and introduce new processes and equipment, including creating procedures and manufacturing methods.
Analyze process data to identify trends, root causes, and improvement opportunities.
Drive and support process optimization, continuous improvement projects, and change control activities.
Ensure validations are completed on time and aligned with project timelines and manufacturing schedules.
Follow organizational policies, standard work instructions, and applicable safety regulations; attend required training and meetings.
Complete assigned tasks efficiently and on time, organize work, set priorities, and meet productivity standards.
Promote and maintain a safe work environment by identifying and reporting hazards and supporting team and site safety initiatives.
Demonstrate initiative and accountability, adapt to changes, and follow through on commitments and responsibilities.
Participate in department and quality team meetings and propose and support process improvements.
Support fellow process engineers, project engineers, and operations staff in equipment design and reliability improvement efforts.
Contribute to continuous improvement activities and initiatives across the organization.
Assist in training new team members or trainees as needed.
Travel up to 25%, including customer visits, other Datwyler sites, training, and equipment vendor visits for factory acceptance tests.