12 days old

Validation Engineer

Gray Solutions, A Gray Company
Lexington, KY 40507
  • Job Code
At Gray Solutions our mission is to be Trusted Advisors Delivering Outcome Based Solutions Through Deep Collaboration and Lasting Partnerships, While Providing Fulfilling Team Experiences.

Formed in 2018, Gray Solutions, a Gray company, is a leader in automation and process integration for customers in the Food & Beverage market. Our creative approach to optimizing complex integrated processes allows us to deliver fast, transformative results for projects of all sizes.

Gray is a fully integrated service provider deeply rooted in engineering, design, and construction services. As a family and employee-owned company, we focus on the manufacturing, food & beverage, automotive, distribution, mission critical, and commercial markets for domestic and international customers. The Gray family of brands provides specialized capabilities across key markets and customers. Together, we deliver highly customized solutions that meet customers most sophisticated needs.

Job Requirements

  • Candidate shall have minimum 3 years related experience in a highly regulated industry, such as consumer products, pharmaceuticals, or medical devices.
  • Experience and/or requisite knowledge in measuring, analyzing, and calibrating equipment and processes.
  • Bachelor's degree from four-year college or university in engineering related discipline; other fields considered with relevant work experience.
  • Strong leadership and effective communication skills are required to support coordination among customers, vendors, subcontractors, and other project team members.
  • Familiarity with CX Alloy commissioning management software or similar platform a plus.
  • The new team member should be an energetic, self-motivated individual who enjoys a team environment, as well as a passion for collaboration and professional development. If you are a high achiever striving to exceed expectations in a fast-paced innovative company, then Gray Solutions is the place for you.
  • The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Functions
  • Lead validation activities and execution of the site validation master plan.
  • Develop and manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports, and associated risk assessments.
  • Consult relevant team members and customers to determine validation objectives and standards.
  • Review and support design deliverables to include P&ID walk-downs, systems drawings, specifications, engineering change orders, and equipment selections.
  • Ensure validation status of equipment and associated systems meet cGMP and regulatory compliance.
  • Work in conjunction with Commissioning Manager to execute test run protocols and associated troubleshooting activities.
  • Analyze data to determine if processes/systems meet the stated criteria and specifications.
  • Maintain records of validation activities.
  • Where applicable, participate in and support project schedule development from proposal to start-up, commissioning, and training/turnover.
  • Participate in development and management of the start-up, commissioning, and turn over budget.
  • Develop trusted relationships with customers, key vendor suppliers and design/installation partners. Integrate customers operations and vendor/sub-contractor activities into program commissioning plan.
  • Basic knowledge of equipment common to food, beverage and consumer products processing and understanding common requirements for effective integration into a program level commissioning plan are a plus.
  • Candidates should be able to complete work without help from others but may also be responsible for managing multiple project plans, vendors, customer relationships and larger teams.

Physical Demands & Work Environment
  • The physical demands described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this position, the team member is frequently required to stand, walk, sit, use hands, reach with hands or arms, and talk or hear. They may occasionally be required to climb or balance, stoop, kneel, or crouch. Must occasionally lift and/or move up to 30 pounds. Specific vision abilities required include close vision.
  • Travel to customer and project locations as required (50-75%).

Supervisory Responsibilities
  • Although not initially, this position may grow to supervise other team members, as well as subcontractors and partners.

EEO Disclaimer

  • Our Company will be proactive in employing and advancing qualified individuals regardless of race, color, religion, sex, national origin, age, disability, genetic information, protected veteran status, or any other protected status.

Posted: 2021-09-11 Expires: 2021-10-10
Sponsored by:
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Sponsored by:
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Validation Engineer

Gray Solutions, A Gray Company
Lexington, KY 40507

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