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

Job Description

Required Education:

• Bachelor’s Degree

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

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

• 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.