Process Engineer

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