Duties

• Supervise work of Validation Engineers, Scientists, and contractors.
• Participate in the development of validation protocols for equipment, products, software, and processes.
• Reviews engineering change orders and assesses criticality of any process changes to determine if validation is affected.
• Reviews maintenance service work and determines if status of equipment or environment validation is affected.
• Review current validation processes and recommend process improvements.
• Monitor and direct the performance of validation studies conducted by the Technical Validations Department.
• Coordinate the activities of the validation group with the activities of other departments through project planning.
• Ensure proper validation status of equipment throughout facility.
• Provide validation support for new product and process development.
• Prepare and submit process validation plans and process validation summaries.
• Understand and assure conformance to federal regulations and ISO standards.
• Train Technical Validations staff as needed.
• Supply troubleshooting support to help identify the causes of product/production related problems and maintain accurate documentation.
• Prepare and administer performance appraisals of Validation Staff.
• Maintains department budget and controls spending.

Qualifications Required:

Education:
BS/MS/PhD in Chemical, Electrical or Mechanical Engineering or BS/MS/PhD in Biology, Chemistry, Biochemistry or equivalent.

Skills and Abilities:
• Technical writing skills: QSR documents, Device Master Records, Device History Records, SOPs, research proposals and reports, Gantt / tracking charts.
• Good communication and decision making skills
• Ability to manage at all levels of scientific or engineering staff
• Ability to communicate with scientists in other disciplines, including biochemistry, and microbiology
• Capable of using Microsoft Word, Excel and PowerPoint
• Capable of performing statistical evaluations, preparing trend charts

Experience:
• Minimum 7-10 years experience in an in vitro or pharmaceutical manufacturing setting conducting product and process validations.

Physical Demands:
• Able to work on the floor to solve manufacturing and equipment problems.
• Available for travel up to 10% of time.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.