Position Opening (Posting Date 20 August 2026)

• Job title: Process Engineer

• Job location: South Bend, IN

• Number of positions: 1 opening.

• Offered Salary: $86,000.20 per year.

• Job duration: Permanent position, Full time, Mon - Fri, 40 hours per week.

• Job Description: Perform IQ/OQ/PQ validation testing for equipment, Water System, utilities, and cleanroom environments. Validate the analytical data sheets and implement the process in eQMS system. Ensure all processes comply with industry regulations, including GMP (Good Manufacturing Practices) and 21 CFR Part 11. Maintain accurate and detailed documentation of process changes, validations, and standard operating procedures (SOPs). Develop and execute commissioning, qualification, and validation protocols for required equipment and systems. Work closely with crossfunctional teams, including Production, Quality Assurance, Validation to support process improvements. Write and review Batch Records, SOPs, Process Validation Protocols, and other technical reports. Calibrate HVAC and process equipment per SOPs Conduct environmental monitoring for Temperature, Relative Humidity, and Differential Pressure.

• Education and Experience required: Bachelor’s degree or equivalent in Chemical Engineering or Mechanical Engineering or Industrial Engineering plus 6 months experience in job offered or as QC Analyst or Engineer or related field. Prior work experience must include 6 months experience in Calibrating HVAC, IQ/OQ/PQ validation testing, compliance with cGMP and 21

• CFR Part 1.

• Mail resume to Paras Shah c/o Hubot, Inc d/b/a Tri-Pac, Inc, 3333 North Kenmore St, South Bend, Indiana 46628. Ref: TP-5