Associate Process Engineer – Validation & SOP Expert

System One, Inc.; Mahwah (NJ); On-site; USD 55,000 - 62,000; Part time

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

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.