Senior Validation Engineer - Manufacturing
Experis Harmans, MD
- Expired: over a month ago. Applications are no longer accepted.
The Senior Validation Engineer will work in an FDA regulated clean room environment, this position is responsible for validation of bio process equipment and GMP utilities. We are seeking a candidate with experience in commissioning of a new facility with a hands-on approach to working with others to accomplish goals and objectives. This role is a 6 month contract with possibility of extension or direct-hire conversion.
· Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility
· Project based work will be in 3 main areas: Equipment Qualification, HVAC/Clean Room Qualification, and Temperature Mapping (Kaye Validator and/or AVS)
· May also develop Validation Master Plans, Validation Project Plans and Project Schedules as needed
· Oversees the timely completion of all validation documentation, including coordination of contractor activities
· Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable
· May interact with internal clients and external vendors on equipment/process requirements
· Support the maintenance of the validation program for facilities and equipment
· Support changes through the provision of necessary validation documentation and change control activities
· Support the regulatory defense of validation protocols and summary reports during audits and internal audits
· Develop and support continuous improvement initiatives for the validation of equipment, facility, utility, and control systems
· Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures. Collect and analyze data to make data driven recommendations/decisions
· Participate in equipment failure investigations
· Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality and Facilities Engineering
· Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies
Education & Experience
· B.S. in Engineering or Science discipline
· 5+ years of validation experience in a GMP environment
· At least one (1) year of direct experience in the validation of fermenters and autoclaves
· Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable
· Working knowledge of Kaye/Amphenol datalogging equipment (Validator, AVS, ValProbe)
Experis is a global leader in professional resourcing and project-based workforce solutions. We deliver in-demand talent for mission-critical positions, enhancing the competitiveness of the organizations and people we serve. Our goal is to maintain a positive candidate and client experience through fitting the best candidates with the best positions.
#1 Global Supplier of the Year! Experis is a global leader in professional resourcing and project-based workforce solutions. We deliver in-demand talent for mission-critical positions, enhancing the competitiveness of the organizations and people we serve. Our goal is to maintain a positive candidate and client experience through fitting the best candidates with the best positions.