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Role:
The Instrument Validation Specialist will support a diverse variety of Quality Control and Manufacturing instrumentation, including analytical and microbiological instruments, maintaining the validated state of the instruments from implementation through their full lifecycle. This role will also provide technical support for continuous improvement projects, including data integrity initiatives, driving the projects to completion to support the ongoing activities within the laboratory and manufacturing environments.
Role Responsibilities
This position will provide support for the Validation Program and Validation projects.
Work with Operations, Quality, Technical groups, and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
Plan and coordinate the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols, and Impact / Risk Assessments.
Providing technical support and participating in the implementation of change controls and commitment action items
Providing technical support and supporting ongoing investigations
Maintaining inspection readiness
Technical understanding of process and instrumentation to be qualified
Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS),Laboratory Information Management System (LIMS), Empower and/or Chromatographic applications and document repositories
Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
Role will be expected to work Monday Friday standard shift. Weekends or off hours may be required as needed.
The incumbent in this position will be responsible for supporting and implementing the established validation approach. Assisting with supporting the site's successful adherence to the Validation Master Plan, Validation SOP's, and that validation executions meet all applicable for the client quality and compliance standards and applicable regulatory standards
Basic Qualifications
The position requires BS engineering or science degree with 4 years of experience or a MS engineering or science degree with 2 years of experience or equivalent. The required experience is in the area of validation activities supporting manufacturing and development operating in regulated environment. Candidate is required to be experienced with Pharmaceutical Validation requirements and/or Medical Device Validation requirements (CFR 811)
Experience also required: background in problem solving, negotiations, data integrity principles, and project management/support in a matrixed reporting environment
Role:
The Instrument Validation Specialist will support a diverse variety of Quality Control and Manufacturing instrumentation, including analytical and microbiological instruments, maintaining the validated state of the instruments from implementation through their full lifecycle. This role will also provide technical support for continuous improvement projects, including data integrity initiatives, driving the projects to completion to support the ongoing activities within the laboratory and manufacturing environments.
Role Responsibilities
This position will provide support for the Validation Program and Validation projects.
Work with Operations, Quality, Technical groups, and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
Plan and coordinate the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols, and Impact / Risk Assessments.
Providing technical support and participating in the implementation of change controls and commitment action items
Providing technical support and supporting ongoing investigations
Maintaining inspection readiness
Technical understanding of process and instrumentation to be qualified
Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS),Laboratory Information Management System (LIMS), Empower and/or Chromatographic applications and document repositories
Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
Role will be expected to work Monday Friday standard shift. Weekends or off hours may be required as needed.
The incumbent in this position will be responsible for supporting and implementing the established validation approach. Assisting with supporting the site's successful adherence to the Validation Master Plan, Validation SOP's, and that validation executions meet all applicable for the client quality and compliance standards and applicable regulatory standards
Basic Qualifications
The position requires BS engineering or science degree with 4 years of experience or a MS engineering or science degree with 2 years of experience or equivalent. The required experience is in the area of validation activities supporting manufacturing and development operating in regulated environment. Candidate is required to be experienced with Pharmaceutical Validation requirements and/or Medical Device Validation requirements (CFR 811)
Experience also required: background in problem solving, negotiations, data integrity principles, and project management/support in a matrixed reporting environment