Process Engineer

Process Engineer

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