Our client is currently seeking a

Associate Engineer, Process Engineering Job Title:

Associate Engineer, Process Engineering Duration:

12

Months Location:

Mahwah, NJ Position Summary Develop and modify process formulations, methods, and controls to meet quality standards. Recommend and implement process improvements, modifications, and additions to support manufacturing and validation activities. Review product development requirements for compatibility with processing methods, costs, and schedules. Integrate equipment and material capabilities to meet process and technology specifications. Responsibilities

• Support the drafting, execution, and completion of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for production equipment and manufacturing lines.
• Collect, compile, analyze, and interpret process and experimental data using statistical methods.
• Author validation protocols, technical reports, and final validation summaries.
• Support engineering change evaluations and assess validation impacts resulting from process or equipment modifications.
• Assist with change control activities and re-validation requirements.
• Draft, revise, and maintain Standard Operating Procedures (SOPs), work instructions, preventive maintenance procedures, and equipment operating manuals.
• Collaborate with engineering teams to create and update process documentation for new technologies and manufacturing processes.
• Support process improvement initiatives to enhance efficiency, quality, and reliability.
• Ensure compliance with quality and validation requirements throughout project execution. Required Qualifications
• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• Strong technical writing skills with experience creating SOPs, validation documents, and technical reports.
• Ability to work effectively in a fast-paced environment and manage multiple priorities.
• Strong analytical, problem-solving, and organizational skills.
• Ability to collaborate with cross-functional engineering teams. Preferred Qualifications
• Hands-on mechanical aptitude and troubleshooting experience.
• Validation experience, including

IQ/OQ/PQ

protocol development and execution.

• Experience with design reviews and engineering documentation processes.
• Experience with OnePLM and/or Windchill.
• Knowledge of manufacturing processes, quality systems, and process engineering principles.

Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.