Cleaning Validation & Commissioning Specialist
North Chicago, IL, United States On-site
$84,500–$162,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.
What you'll bring
- Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
- Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
- Ability to supervise junior or contract team members
- Ability to manage complex projects and multiple projects (5+) simultaneously
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
- Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence
- with a desired 3+ years of significant engineering and/or operational experience.
- 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
- prior supervisory experience preferred