Kappa Search | Chicago Employment Agencies | Validation Engineer Job

Kappa Search Inc. (KSI) is a Chicago employment agency specializing in the recruitment and placement of technology, engineering, operations, manufacturing and sales professionals in a variety of fields. One of our clients is a well-established leader in the medical products industry. This company is in a solid growth mode and is looking to expand their validation department. The Validation Engineer position responsibilities and requirements are as follows:

Will maintain the Master Validation plan and perform quality assurance requirements for process validation, which may include test protocols and reports and validation run. Will perform equipment calibration as assigned.

ESSENTIAL FUNCTIONS:
1. Supports and promotes all company policies, including Safety Policies.
2. Supports and maintains the quality system.
3. Serves as a Quality Assurance resource to assigned departments.
4. Reports to Quality management on quality concerns, trends and costs.
5. Responsible for assuring that product and process validations meet regulatory, corporate, division, and local plant requirements.
6. Maintains the Master Validation Plan
7. Generates the product and process validation protocols.
8. Coordinates QA Tech activities during product and process validations.
9. Participate in new product and process development to assure Validation is addressed
10. Performs or arranges the QA tests required b the Validation protocols.
11. Analyzes causes of defects and participates in recommendation of corrective actions for issues raised during Validation.
12. Assists in the preparation of inspection instructions, systems and procedures to ensure Validation results are incorporated as required.
13. Initiates actions to dispose of nonconforming product from Validations.
14. May be responsible for the equipment Calibration system.
15. Other duties as assigned by supervision

Education required/preferred:

  • 4 year college degree required. Degree in a technical discipline preferred.
  • Experience working in a similar manufacturing environment where product and process validation is required.
  • Experience working with validations is preferred.
  • Practical knowledge of plastics injection molding technology; adequate interpersonal skills at all levels of the organization.

Skills/Competencies:

  • Good communications skills, both written and oral.
  • Good computer skills (Microsoft Office and Minitab).