Engineer Process (Mid Level)

Job Title Process Engineer (Equipmentation & Design Transfer)
Job Location Type In Person
Location Richmond IL 60071
Job Type 5-Month Contract
Shift Schedule Standard Day Shift Monday Friday 8 Hours/Day

We are seeking a highly motivated Process Engineer to lead process validation risk management and design transfer activities within a regulated manufacturing environment. This role will work cross-functionally with engineering quality validation and manufacturing teams to support product development process implementation and equipment qualification initiatives.

The ideal candidate will have strong experience in Process Validation (IQ/OQ/PQ) Risk Management (FMEA) and ISO 13485-compliant environments with the ability to manage technical documentation and drive projects from planning through execution.

• Lead and coordinate cross-functional project teams to achieve project milestones and deliverables
• Manage weekly project meetings action items and status updates
• Coordinate process validation activities and equipment installation efforts across site teams
• Ensure project timelines documentation and validation activities remain on track

• Serve as Process Validation Owner for manufacturing processes and equipment
• Author execute review and approve:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Support validation strategy development and implementation
• Ensure validation activities comply with regulatory and quality system requirements

• Develop and maintain Risk Management documentation
• Perform and facilitate:
  • Process FMEA (pFMEA)
  • Risk Assessments
  • Mitigation Planning
• Support Design Transfer activities and product commercialization efforts
• Author and review Design History File (DHF) documentation

• Apply statistical analysis tools to evaluate process performance
• Support Design of Experiments (DOE) activities
• Participate in Test Method Validation (TMV) development and execution
• Analyze process data and recommend improvements to enhance quality and efficiency

Experience in one or more of the following manufacturing areas is highly desirable:

• Blending operations
• Formulation development
• Mixing dynamics
• Tank and vessel design

• Liquid filling systems
• Dispensing equipment
• Capping systems
• Labeling equipment
• Packaging and assembly processes

• UV Spectroscopy
• pH Measurement Systems
• Viscometers
• Moisture Analyzers
• Process Monitoring Equipment

• Bachelors degree in Engineering or related technical discipline
• Minimum 2 years of engineering experience in a regulated industry
• Hands-on experience with:
  • Process Validation (IQ/OQ/PQ)
  • Risk Management (FMEA)
  • Design Controls
  • Design Transfer
• Knowledge of:
  • ISO 13485
  • Regulated Quality Systems
  • Validation Lifecycle Documentation
• Strong project coordination and technical documentation skills
• Proficiency with Microsoft Office Suite

• Experience in Medical Device Pharmaceutical Biotechnology or other regulated manufacturing industries
• Knowledge of:
  • Design of Experiments (DOE)
  • Test Method Validation (TMV)
  • Statistical Analysis Tools
  • ISO 9001 Quality Systems
• Experience leading validation projects and cross-functional teams
• Familiarity with manufacturing process development and scale-up activities

• Strong technical writer with experience authoring validation and quality documentation
• Skilled at collaborating across engineering quality and manufacturing teams
• Detail-oriented with strong analytical and problem-solving abilities
• Comfortable managing multiple priorities in a fast-paced regulated environment
• Experienced in driving validation and risk management activities from planning through execution