Associate Engineer, Process Engineering

Job Title: Associate Engineer, Process Engineering - Individual Contributor

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.

Entry Level: Mechanical Engineering Proficient technical writer (SOPs, Validations) Works under pressure, Work with other engineers to create and update process documentation for new technology & process to the company.

NICE to have:
Hands on, mechanically inclined OnePLM/Windchill experience Validation experience Design review