What are the responsibilities and job description for the Validation Manager position at IntelliHive?
Validations Manager
Location: Jackson, MO | Salary: $75,000 - $100,000
About the Role
IntelliHive is proud to partner with a global leader in providing medical device supplies. Our client is seeking a Validations Manager to lead and oversee validation activities, ensuring compliance with industry regulations and quality standards. This role is critical in managing customer validation processes, supervising technical staff, and maintaining high-quality performance in our operations.
Key Responsibilities
- Team Leadership – Supervise and manage the Validation Technical Support Staff, ensuring efficient workload distribution and professional development.
- Protocol Review & Approval – Assess and approve customer-provided validation protocols, including Process Performance Qualification (PQ), Microbiological Performance Qualification (MPQ), and routine cycle requalifications, ensuring compliance with company and industry standards.
- Validation Processing Management – Oversee customer validation activities, including process cycle setup, equipment configuration, and direct collaboration on final cycle development.
- Technical Oversight – Assign and monitor validation activities performed by the technical team to ensure adherence to best practices and regulatory requirements.
- Performance & Quality Analysis – Provide annual summary reports on validation activities, identifying quality trends and performance improvements.
Qualifications & Experience
Education – Bachelor’s degree required (STEM preferred).
Experience – Minimum 3 years in quality assurance, validations, engineering, or a related field.
Regulatory Knowledge – Strong understanding of:
- ISO 11135 (Ethylene Oxide Sterilization)
- ISO 13485 (Medical Device Quality Systems)
- CFR 820 (FDA Quality System Regulations)
Why Join?
✔ Opportunity to lead and shape validation processes in a regulated industry.
✔ Work with cutting-edge technology and ensure compliance in a critical field.
✔ Competitive salary with career growth opportunities.
Apply Now to take the next step in your career! Please email Andrew (ahogg@intellihive.com) to share your resume and qualifications.
Job Type: Full-time
Pay: $75,000.00 - $100,000.00 per year
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- Do you have knowledge of ISO 11135 (EO Sterilization standard), ISO 13485 (International Quality Systems standard), and CFR 820 (FDA Quality System Regulations)? (Please type: No, somewhat familiar, very familiar, or expert).
Education:
- Bachelor's (Preferred)
Experience:
- quality assurance, validations, engineering, or related: 3 years (Required)
Ability to Commute:
- Jackson, MO 63755 (Required)
Work Location: In person
Salary : $75,000 - $100,000