Associate Process Engineer

System One, Inc.

Mahwah (NJ)

On-site

USD 55,000 - 62,000

Part time

2 days ago
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Job summary

System One is seeking an Associate Process Engineer for an onsite contract in Mahwah, New Jersey. You will develop and modify process formulations and controls to meet quality standards, and support IQ/OQ/PQ protocols for production lines.

You will draft SOPs, analyze data, and participate in ECO assessments, working in a collaborative environment with hands-on validation experience preferred.

Qualifications

  • Mechanical Engineering Proficiency.
  • Proficient technical writing skills (SOPs, Validations).
  • Ability to work well under pressure.
  • Works well in a collaborative environment.

Responsibilities

  • Develops and modifies process formulations, methods and controls to meet quality standards.
  • Recommends and implements improvements, modifications or additions to document work.
  • Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
  • Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
  • Drafts and executes IQ/OQ/PQ Protocols for production lines and equipment.
  • Collects, analyzes experimental and process data using statistical methods and writes validation reports.
  • Supports ECO evaluation and validation impact assessment on process modifications.
  • Drafts and updates SOPs, maintenance procedures, and equipment operating manuals.

Skills

Mechanical engineering
Technical writing
Under pressure
Collaborative environment

Tools

OnePLM
Windchill

Job description

Job Title: Associate Process Engineer
Location: Mahwah, New Jersey
Type: Contract
Compensation: $40- 45/hr
Work Model: Onsite

Responsibilities
  • Develops and modifies process formulations, methods and controls to meet quality standards.
  • Recommends and implements improvements, modifications or additions to document work.
  • Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
  • Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
  • Draft & Execute IQ/OQ/PQ Protocols: Support the authoring, execution, and closing of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for production lines and equipment.
  • Data Analysis & Technical Reporting: Collect, compile, and analyze experimental and process data using statistical methods; author clear, concise validation final reports.
  • Change Control & Re-validation: Support the evaluation of Engineering Change Orders (ECOs) and process modifications to determine validation impact and execution requirements.
  • Standard Operating Procedures (SOPs): Draft and update work instructions, preventative maintenance procedures, and equipment operating manuals based on validated parameters.
Requirements
  • Mechanical Engineering Proficiency
  • Proficient technical writing skills (SOPs, Validations)
  • Works well under pressure
  • Works well in a collaborative environment
Preferred
  • Hands on experience
  • Mechanically inclined
  • OnePLM/Windchill experience
  • Validation experience
  • Design review

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific

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