Cleaning Validation & Commissioning Specialist
$84,500–$162,000 year
On-siteNorth Chicago, Illinois, United States
Job Summary
Develop and execute commissioning, qualification, and validation test protocols for new and modified equipment, facilities, utilities, products, and processes. Lead execution of risk management by reviewing documentation, estimating ratings, and facilitating FMEA authorization while establishing team work practices. Coordinate and execute sampling for cleaning validation, document results, and prepare area reports and presentations. Generate and process change requests, implement special projects, and supervise contract validation resources to ensure timely activity completion. Provide assistance to operations regarding environmental, health, and safety systems and promote continuous improvement.
Required Qualifications
- Bachelor's Degree in Engineering, science, or closely related discipline
- 3+ years of significant engineering and/or operational experience
- 6+ years of overall experience in Manufacturing, Quality or Engineering
- Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny
- Ability to supervise junior or contract team members
- Ability to manage complex projects and multiple projects (5+) simultaneously
Desired Qualifications
- Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny
- 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.)
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing
- Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment
- Prior supervisory experience
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