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COMMISSIONING / VALIDATION SPECIALIST / ENGINEER
Compliance Technology Group, Inc., is currently seeking Commissioning/Validation Specialists/Engineers to work a variety of regulated industry projects. Qualified candidates will participate in startup, commissioning and validation activities for our clients within FDA regulated industries including pharmaceutical, biotechnology, medical device, and medical diagnostic.
Commissioning/Validation Specialists/Engineers will be able to develop and/or execute the following documents:
· URS (User Requirement Specification)
· FRS (Functional Requirement Specification)
· DDS (Detailed Design specification)
· FAT (Factory Acceptance Testing)
· SAT (Site Acceptance Testing)
· CSV (Computer System Validation)
· IQ (Installation Qualification)
· OQ (Operational Qualification)
· PQ (Performance Qualification)
Requirements:
Other responsibilities include maintaining direct communication with Project Managers or CTG upper level management and clients to ensure the commissioning/validation plans are properly implemented in compliance with corporate and federal policies and procedures.
· Bachelor's or Master's degree in Biology, Engineering, Chemistry, or related
 subject with 1+ years of experience in the biopharm industry
· A thorough understanding of the GMP regulatory environment, validation, and
associated subjects
· An ability to work independently
· Excellent verbal and written communication skills
· Proficiency in Windows and Microsoft Office applications
· Knowledge of cleaning / method / process validation a plus
To apply to CTG career opportunities, email your resume to:
careers@ctg-gmp.com or fax your resume to: 484.356.0549
Attention: Human Resources Manager
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