Process Engineer

Datwyler Group

. Lead washing processes to ensure products meet regulatory requirements and customer delivery timelines .

Posted 10/15/2026full-timeMiddletown • New Jersey • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in process engineering within regulated manufacturing environments, focusing on validation principles, washing processes, and continuous improvement methodologies. Proficient in collaborating across teams to enhance product quality and operational efficiency while ensuring compliance with regulatory standards.

Highest-signal resume keywords

Process EngineeringValidation PrinciplesRegulatory ComplianceContinuous ImprovementWashing Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process OptimizationValidation Master PlansCycle DevelopmentTest Data AnalysisPreventive MaintenanceManufacturing ProceduresProblem-SolvingHigh-Purity Water SystemsClean Room ProcessingEndotoxin Test Methods

Soft Skills

Effective CommunicationCollaborationTrainingProblem-SolvingCross-Functional Teamwork

Tools & Technologies

MESSAPMIIManufacturing EquipmentAutomated Systems

Industry Keywords

Regulated ManufacturingUSP RequirementsLean MethodologiesSix SigmaParenteral Use

About the role

Key responsibilities & impact

Lead washing processes to ensure products meet regulatory requirements and customer delivery timelines
Develop cycles and apply and introduce best practices
Create and apply re-qualification programs and validation master plans
Create and review process user requirements, validation documents, and verification procedures
Manage validation of new designs, re-qualification practices, cycle development, and process improvements
Address cycle failures through short-term and long-term preventive plans
Review and recommend procedures and process enhancements to improve efficiency and product quality
Analyze test data against established protocols and develop validation strategies for anomalies and deviations
Define preventative maintenance and calibration schedules where required
Collaborate on and train employees on new procedures and address instruction-related concerns
Provide day-to-day process engineering support to 24/7 manufacturing operations
Troubleshoot issues and ensure stable production processes
Plan, execute, and document validation activities for processes, equipment, and systems
Collaborate with production, quality, and maintenance teams on existing and new processes and equipment
Create new manufacturing procedures and methods
Analyze process data to identify trends, root causes, and improvement opportunities
Drive process optimization, continuous improvement, and change control activities
Ensure validations are completed on schedule and aligned with project and manufacturing timelines
Follow organizational policies, work instructions, and safety regulations
Promote a safe working environment and support site safety initiatives
Participate in department and quality team meetings and support process improvements
Support process, project, and operations teams with equipment design and reliability improvements
Assist with continuous improvement initiatives and train new team members as needed
Cover two sites in Pennsauken, New Jersey, and Middletown, Delaware

Requirements

What you’ll need

A Bachelor's degree in Chemical, Mechanical, Biomedical, or a related engineering discipline
Knowledge of washing processes
Effective verbal and written communication skills
5+ years of experience in a process engineering role, ideally in a regulated manufacturing environment
Working knowledge of high-purity water systems (PW, WFI, clean steam) and 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 washing primary packaging components 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 manual and automated manufacturing practices, including mixing, pumps, process piping, chemical dosing, and automated parts feeding and inspection systems, is preferred
Exposure to Lean, Six Sigma, or other continuous improvement methodologies
Familiarity with manufacturing systems such as MES, SAP, and MII
Willingness to travel up to 25%, including customer visits, other Datwyler sites, training, and equipment vendors for FATs

Benefits

Comp & perks

Training and assignments in a global environment
Interesting development opportunities
Diversity and a wide range of career opportunities
Opportunities to contribute creativity and ideas
Respectful, trusting, and appreciative work environment