American Regent, Inc. Validation Specialist in Shirley, New York
Write, execute, and summarize validation protocols for pharmaceutical manufacturing equipment.
Essential Duties and Responsibilities
Develop validation strategies; prepare equipment validation protocols (FAT, IQ/OQ, and PQ)
Execute equipment validation protocols
Analyze test data and make recommendations
Perform investigations and troubleshoot issues related to validation, as necessary
Prepare written validation reports for performance qualifications
Develop validation plans for equipment changes
Perform maintenance validation testing on the following types of equipment: terminal sterilizers, equipment sterilizers, automated visual inspection equipment, depyrogenation tunnels, and packaging equipment
Qualifications and Requirements
Associates degree with related pharmaceutical equipment validation experience is required; or Bachelors' of Science degree in Engineering (preferred)
2+ years of pharmaceutical equipment validation experience, preferred
Strong technical writing skills
Proficiency in Microsoft Excel and Word
Physical Environment and Physical Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
Select this statement if a respirator is required for the role. Otherwise, delete.
Employee must be able to occasionally lift and/or move up to 50 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees.
American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Roz Russo, Talent Acquisition Senior Manager at 631-205-2068 or email at
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.