Associate Process Engineer -27757

iMPact Business Group; Mahwah (NJ); On-site; USD 39,000 - 69,000; Full time

Job summary

iMPact Business Group is seeking an Associate Process Engineer for a 12-month+ contract in New Jersey. The role focuses on developing and modifying process formulations, methods, and controls to meet quality standards, with emphasis on IQ/OQ/PQ protocols and data-driven validation.

The ideal candidate has a mechanical engineering background, strong technical writing skills for SOPs and validation, and a hands-on, collaborative approach to work under pressure.

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• Strong technical writing skills for SOPs and validation documentation.
• Ability to collaborate with other engineers and work under pressure.
• Hands-on, mechanically inclined approach.

Responsibilities

• Develop and modify process formulations, methods, and controls to meet quality standards.
• Recommend and implement improvements to process documentation.
• Review product development requirements for compatibility with processing methods.
• Integrate equipment and material capabilities to meet spec target specifications.
• Draft and execute IQ, OQ, and PQ protocols for production lines and equipment.
• Collect, compile, and analyze experimental data and author validation reports.
• Support ECO evaluations and determine validation impacts and execution needs.
• Draft and update work instructions and preventive maintenance procedures.

Skills

Mechanical engineering

Technical writing

Collaboration

Hands-on

Education

Bachelor's degree in Mechanical Engineering

Job description

Our client, a Global Leader in the Medical Device Industry, has an immediate opening for an Associate Process Engineer for a 12-month+ contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.

Key Responsibilities:

• Developing and modifying process formulations, methods, and controls to meet quality standards.
• Recommending and implementing improvements, modifications, and additions to process documentation.
• Reviewing product development requirements for compatibility with processing methods and determining costs and schedules.
• Integrating equipment and material capabilities to meet process module and technology target specifications.
• Drafting and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for production lines and equipment.
• Collecting, compiling, and analyzing experimental and process data using statistical methods and authoring clear, concise validation reports.
• Supporting the evaluation of Engineering Change Orders (ECOs) and process modifications to determine validation impacts and execution requirements.
• Drafting and updating work instructions, preventive maintenance procedures, and equipment operating manuals based on validated parameters.

Requirements:

• Mechanical engineering background suitable for an entry-level process engineering role.
• Strong technical writing skills, particularly for SOPs and validation documentation.
• Ability to work effectively under pressure and collaborate with other engineers.
• Hands‑on, mechanically inclined approach.