Manufacturing Process Engineer - Equipment Validation (IQ/OQ/PQ)

Required Skills: Experience in mechanical engineering, manufacturing engineering, or process engineering, preferably in a production environment. Hands-on experience drafting, executing, or supporting IQ/OQ/PQ validation protocols for manufacturing equipment or production processes. Demonstrated ability to write, revise, and maintain detailed SOPs, work instructions, equipment manuals, and process documentation. Experience collecting and analyzing process or experimental data and preparing technical reports to document validation results and process performance. Exposure to engineering change orders (ECOs), change control, process modifications, and revalidation assessments.

Preferred Skills: Mechanically inclined OnePLM/Windchill experience Validation experience Design review

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.

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.