Validation Leader/Specialist

A job is just a job, but there is no substitute for a career working with cutting edge technology. This is a position that requires hard for big gains. It is a search for a few good people who want to contribute to being a part of the best. If you know the value of Validation and why it is necessary to the success of product launches then this may be a career path for you.


The Validation Leader must have demonstrated knowledge of GMP facilities and cGMP requirements. The position is responsible for the management and execution of validation projects involving manufacturing equipment, facilities and utilities. The position is also responsible for the maintenance of the validated state of faciltities/equipment via periodic re-qualification. The incumbents must plan, oversee, and execute validation projects from inception to completion. Must take primary responsibility for the validation for facility shutdowns. A strong past history of developing validation department documents including: Validation Master Plans and Standard Operating Procedures. Other responsibilities include FMEA and performance studies. Assists with regulatory agency interactions and advises other validation team members.


Must possess expertise in equipment/facilities/utilities validation. The position requires independent judgment, strong leadership, and excellent technical knowledge. The applicant should be well versed in WFI systems, HVAC systems, clean rooms, sterilization methods, and sanitization methods. A demonstrated ability to mentor and develop junior staff members is also necessary.


Job duties will include, but not limited to the following:


Writing of Validation Protocols such as IQ, OQ and PQs

Execution of Validation Protocols such as IQ, OQ and PQs

Calculation and interpretation of data for Facilities & Equipment Validation Studies

Excel Spreadsheet Generation and Summary Report Writing for PQ studies

 Review and modify Standard Operating Procedures (SOPs)

Generate test procedures to validate new or previously unvalidated equipment/faciltities

QA Review of documents


Participate in and conduct any or all of the following types of validation:


Cleaning Validation

Process Validation

Equipment Validation

SIP/CIP Validation Risk Assessments


Qualifications: A BS degree or equivalent in Engineering, Chemistry or the Life Sciences is required. Minimum of 5 years experience in facility/equipment/utilities validation within a pharmaceutical, biotechnology, medical device, or related industry. Applicants must be familiar with CFR and ISO requirements. Must have excellent communication ability including both oral and written skills.