Project Manager - Western Region

Description:

cGMP Validation, L.L.C. is seeking an experienced Project Manager to participate in validation and GMP compliance activities in the Western region. Qualified candidate should have direct experience within FDA regulated industries and will be responsible for on-site project activities related to pharmaceutical manufacturing, coordination of resources, managing project budget and schedules, and serving as the liaison to clients.

Responsibilities also include providing validation expertise and approaches tailored to meet the specific needs of clients in a practical, cost-effective manner.

Requirements:

• Bachelor's degree or higher in Chemistry, Life Science, Engineering or related subjects
• 5+ years' validation experience in the pharmaceutical, biotech, medical device or medical diagnostic industries with background in project management
• A thorough understanding of the GMP regulatory environment and associated subjects
• Excellent verbal and written communication skills
• Proficiency in MS Office applications

For career opportunities, email careers@cgmpvalidation.com or
fax resume to 913-384-2252 Attention: Human Resources Manager.

Validation Specialists

Description:

cGMP Validation, L.L.C. is currently seeking experienced Validation Specialists to participate in validation and GMP compliance activities for our clients. The Validation Specialist will report to a regional Director. Work locations are throughout the United States and extensive travel should be anticipated.

Qualified candidate should have direct experience within FDA regulated industries. Responsibilities include the development, execution, and final reporting for equipment and utility IQ, OQ, PQ protocols. Experience with cleaning, computer, and/or process validation (utilities and equipment with emphasis on automated equipment validation) is also desirable. Other responsibilities include insuring that validation plans are properly implemented in compliance with corporate and federal policies and procedures.

Requirements:

• Bachelor's or Master’s degree in Chemistry, Life Science, Engineering or related subjects.
• 3+ years' experience in the biopharmaceutical, medical device or diagnostic industries
• A thorough understanding of the GMP regulatory environment, validation, and associated subjects
• Excellent verbal and written communication skills
• Proficiency in Microsoft Office applications
• An ability to work independently

For career opportunities, email careers@cgmpvalidation.com or
fax resume to 913-384-2252 Attention: Human Resources Manager.