Go back to the Job List
Validation EngineerPosted by: Nexgen Pharma
Posted date: Apr-17-2014
Location: Colorado Springs, CO
Bachelor’s degree in life sciences or engineering or related concentration. 5 + years experience in a highly regulated environment like pharmaceuticals or related field, or equivalent combination of education and experience. Demonstrated experience with validation of commercial processing a packaging. Experience in project management. Strong working knowledge of cGMP and regulatory standards for validation.
Ensures validation studies of the manufacturing and packaging facilities, the utilities serving the facilities, computerized systems and all manufacturing and packaging equipment are validated to the required cGMP standards. Creates and maintains the Validation Master Plan for the site. Author/approves and executes validation protocols and authors/approves the final validation reports. Schedules, plans, manages and executes process validation studies and authoring related plans, summary reports and protocols. Schedules, plans, manages and executes installations, operations and performance qualifications of equipment and utility systems. Presents the Validation System and any validation studies to Regulatory and Client Auditors as required. Perform all assigned activities in accordance with regulatory requirements
Designs, maintains and continually improves the validation system in line with cGMP standards
Implements, reviews and continually improves the validation policies and procedures. Provides technical expertise and guidance on validation policies and procedures and the implementation of those within the Production and Quality functional areas. Oversees Operations and QC analysis during validation studies as required. Determines appropriate validation acceptance criteria and requirements. Oversees laboratory studies conducted in support of validation. Summarizes studies and authors validation reports in compliance with the cGMP standards. Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales. Coordinates and leads the execution of validation for production/packaging manufacturing and cleaning processes. Completes all validation documentation in a timely and compliant manner
Surfaces and investigates exception reports and non-conformances, associated with the validation studies. Troubleshoots and resolves technical issues. Performs Environmental Monitoring. Responsible for Metrology: Calibration, verification and qualification of equipment.
Please submit your cover letter and resume to: sandradurannexgenpharma.com