Process Engineer

Datwyler•Middletown, NJ

23d

About The Position

The Process Engineer leads washing operations to ensure products meet regulatory requirements and customer delivery schedules. The role develops washing cycles, applies and introduces best practices, and establishes a re-qualification program and validation master plan. It requires knowledge of washing and water systems, equipment, control methods, techniques, and documentation. The position supports two sites in Pennsauken, New Jersey, and Middletown, Delaware. The Process Engineer provides day-to-day engineering support to manufacturing in a 24/7 production environment. The role plans, executes, and documents validation activities; supports existing and new processes and equipment; troubleshoots production issues; analyzes process data; and drives optimization and continuous improvement. It also works cross-functionally with production, quality, and maintenance teams, supports equipment design and reliability efforts, and contributes to training and safety initiatives.

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 process engineering; experience in a regulated manufacturing environment is preferred.
Working knowledge of high-purity water systems, including PW, WFI, and clean steam, and the associated 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.
Experience with general manual and automated manufacturing practices, such as mixing, pumps and process piping, chemical dosing, and automated parts-feeding and inspection systems.
Willingness to travel up to 25% beyond the two assigned sites.

Nice To Haves

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