FierceBiotech and FiercePharma Jobs
Validation Manager - Pharmaceutical Clinical Associates, LLC
Jul 30
Location: Malvern, PACategories: Validation Associate
Website: http://www.pharmca.com
Position Description
Our biopharmaceutical client is looking to hire a Validation Manager.
In this role you will be responsible for the development, execution, direction, and maintenance of validation programs for instruments, equipment, computer systems and other utilities and processes. Responsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated. In addition you also will be responsible for the client’s calibration program.
If you have the following, I want to speak with you!
Education and Experience:
Bachelor’s degree in Life Science, Chemistry, or Engineering field with a minimum of 4-6 years of experience in validation of equipment and systems in a regulated biotech or pharmaceutical industry; minimum of 2 years experience managing validation projects required; experience in quality systems highly preferred.
Knowledge Requirements:
•Working knowledge of current Good Manufacturing Processes (cGMPs), FDA regulations (21 CFR Parts 210, 211), Good Automated Manufacturing Processes (GAMP) and 21 CFR Part 11 electronic recordkeeping/electronic signatures
•Hands on experience with validation of analytical instruments, autoclaves, refrigerators/ freezers, and computer software programs
•Preferred knowledge of Good Laboratory Practices regulations
