Senior Validation Quality Engineer/Validation Quality Engineer

Merz Pharmaceuticals USA • Racine, WI

69d

About The Position

This position will provide validation, engineering and technical support for all facilities supporting Manufacturing and Distribution. It will coordinate and execute product and process validations as appropriate to the Quality Department. It will evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. The position will provide direct support to Quality Management/Quality personnel regarding operation of the department and Quality System. It will provide support to other departmental activities as directed.

Requirements

• Bachelor's Degree Physical Science or Engineering, or equivalent experience.
• 2+ years Minimum in Medical Device or Pharmaceutical Industry or similar experience.
• 2+ years Minimum in a Quality Role.
• 2+ years Minimum in a Validation Engineering Role.

Nice To Haves

• Minimum 2 years working with electromechanical devices.
• ASQ Certification as a Quality Engineer or equivalent.

Responsibilities

• Oversee the operation of the Quality System process related to product, process, and/or test method Validation and Re-Validation.
• Oversee the Installation, Operational and Performance Qualification activities for equipment, product, or systems installed including those requiring computerized operation/interfacing.
• Coordinate other activities associated with installation and proper configuration of new equipment as directed.
• Provide assistance to the Manufacturers and R&D departments in the development and validation of new products and Manufacturing/Quality Control processes.
• Review and approve internal operating procedures and specifications.
• Capture data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyze the data for the purpose of Quality Improvement and reporting.
• Provide leadership and direction and promote Quality Improvement Processes.
• Coordinate, and analyze databases associated with oversight of the Quality System and its reporting process.
• Provide quality engineering support for supplier changes and resolution of issues at suppliers.
• Identify new quality improvement initiatives/projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
• Work with manufacturing and other functional groups on manufacturing regulatory compliance issues.
• Support training program by delivering assigned training tasks.
• Support with federal, state, and local regulatory officials during regulatory inspections.
• Support in internal and vendor quality system audits as applicable.
• Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
• Provide support to Quality Management personnel and perform other duties as assigned.

Benefits

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees