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Form of work Description Description/Comment: The 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 position will report to the Equipment Validation Manager.
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.
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, Facilities and Engineering.
Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies
Generates, reviews, and approves qualification protocol(s), for various processes in the facility.
Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management, risk assessment, and auditing functions.
Establish and report on key performance indicators, including use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation.
Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations.
Works closely with management from Manufacturing, QA/QC and Facilities in determining the approach to the execution of validation activities, as applicable.
Support the validation program for process qualification, aseptic processing, and cleaning verification activities.
Provide SME level support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures.
Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control.
Support the Process Validation, CSV, Fill and Finish teams as needed
REQUIREMENTS: Bachelor or Master's degree in Life Science or Engineering field with preference to Chemical/Biochemical Engineering. 1-5 years of validation experience in a GMP environment, supporting equipment qualification and facilities commissioning activities Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable Working knowledge of Kaye datalogging equipment (Validator, AVS, ValProbe) Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 123 7555 Harmans Rd. Harmans 52-1667981 Harmans MD 21077 United States Education: Additional Job Details: 6-month contract to hire Location: BWI: 7555 Harmans Road. Harmans, MD 21077 Shift: 1st - Mon to Fri: 8 am - 5 pm with Max Over-Time: 5-10 hours weekly 100% on-site - Worksite: Reporting to 7555 Harmans Rd, Harmans, MD 21077 Candidates must have: Bachelor or master's degree in Life Science or Engineering field with preference to Chemical/Biochemical Engineering. 1-5 years of validation experience in a GMP environment, supporting equipment qualification and facilities commissioning activities. Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable. Working knowledge of Kaye datalogging equipment (Validator, AVS, ValProbe).
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.
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, Facilities and Engineering.
Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies
Generates, reviews, and approves qualification protocol(s), for various processes in the facility.
Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management, risk assessment, and auditing functions.
Establish and report on key performance indicators, including use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation.
Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations.
Works closely with management from Manufacturing, QA/QC and Facilities in determining the approach to the execution of validation activities, as applicable.
Support the validation program for process qualification, aseptic processing, and cleaning verification activities.
Provide SME level support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures.
Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control.
Support the Process Validation, CSV, Fill and Finish teams as needed
REQUIREMENTS: Bachelor or Master's degree in Life Science or Engineering field with preference to Chemical/Biochemical Engineering. 1-5 years of validation experience in a GMP environment, supporting equipment qualification and facilities commissioning activities Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable Working knowledge of Kaye datalogging equipment (Validator, AVS, ValProbe) Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 123 7555 Harmans Rd. Harmans 52-1667981 Harmans MD 21077 United States Education: Additional Job Details: 6-month contract to hire Location: BWI: 7555 Harmans Road. Harmans, MD 21077 Shift: 1st - Mon to Fri: 8 am - 5 pm with Max Over-Time: 5-10 hours weekly 100% on-site - Worksite: Reporting to 7555 Harmans Rd, Harmans, MD 21077 Candidates must have: Bachelor or master's degree in Life Science or Engineering field with preference to Chemical/Biochemical Engineering. 1-5 years of validation experience in a GMP environment, supporting equipment qualification and facilities commissioning activities. Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable. Working knowledge of Kaye datalogging equipment (Validator, AVS, ValProbe).
