Process Engineer

Datwyler•Middletown, DE

12d•Onsite

About The Position

We are looking for a hands-on and detail-oriented Process Engineer to support daily manufacturing operations and lead the execution of validation activities within our coating process. This role is responsible for both process engineering support and validation responsibilities to ensure smooth production, process improvement, and regulatory compliance.

Requirements

Bachelor’s degree in Chemical Engineering preferred; other engineering disciplines will be considered.
2+ years of experience in a process engineering role, ideally in a regulated manufacturing environment (pharmaceutical, medical device, chemical or biotech preferred).
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.

Nice To Haves

Experience with coating technology and 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.

Responsibilities

Providing day-to-day process engineering support to manufacturing for coating operations, troubleshooting issues and ensuring stable production processes in a 24/7 manufacturing environment.
The planning, execution, and documentation validation activities for processes, equipment, and systems.
Collaborating 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.
Drive and support process optimization, continuous improvement projects, and change control activities.
Ensure all validations are completed on time and in alignment with project timelines and manufacturing schedules.
Follow all organizational policies, standard work instructions, and applicable safety regulations; attend required trainings and meetings.
Complete assigned tasks efficiently and on time; organize work effectively, set priorities appropriately, and meet productivity standards.
Promote and maintain a safe working environment by identifying and reporting potential hazards; actively support team and site safety initiatives.
Demonstrate initiative and accountability; adapt to changes in tasks, team structure, or workplace needs; follow through on commitments and responsibilities.
Participate in department and quality team meetings; propose and support the implementation of process improvements.
Support fellow process engineers, project engineers, and operations staff in equipment design and reliability improvement efforts.
Contribute to and support continuous improvement activities and initiatives across the organization.
Assist in training new team members or trainees as needed.