Director of Validation
We are seeking an exceptional leader who thrives in a fast-paced manufacturing environment to oversee our Validation group to ensure that equipment is qualified, maintained and calibrated properly on schedule complying to guidelines and internal procedures. As Director of Validation, you have the ability to make decisions, and are capable of setting and balancing priorities. You are able to manage multiple projects with frequent changes and are able to coordinate and manage validation activities while involving cross-functional partners. You are able to interact well with all levels. You have a willingness to perform “hands-on” work in a dynamic, fast-paced work setting.
About the Role:
As Director of Validation, you will manage, support, and coordinate the work of the Validation group to ensure equipment is qualified, maintained and calibrated properly on schedule complying to appropriate guidelines / specifications and internal procedures. You will provide leadership in strategy and administration of internal and external programs and processes related to validation activities for the Aldevron Fargo site. You will develop calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements. You will also develop validation protocols meeting industry standards for equipment, utilities and processes to ensure Aldevron’s regulatory compliance in support of client end use. Additionally, you will create and revise Standard Operating Procedures (SOPs).
- Prior biotechnology or pharmaceutical manufacturing or development validation experience in a GMP environment (minimum 7 years required)
- Prior experience managing validation projects
- Experience leading a team
- Experience in the regulatory inspection process
- Excellent interpersonal, written and verbal communication, problem solving and organizational skills
- Demonstrated ability to problem solve and troubleshoot in a manufacturing environment
- Bachelor’s degree required
Who is Aldevron?
Aldevron is a leader in advancing biological science. Our custom development and manufacturing services provide scientists around the world with the essential components to accelerate research and open up their laboratories for groundbreaking science and breakthrough discoveries.
Why Choose Aldevron?
We are in a landmark moment in the history of life science, and Aldevron is at the center of it. With our commitment to quality, we provide career opportunities that allow employees to grow and succeed, while helping make everybody’s lives better.