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Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.b. Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.c. Completes all qualification and validation documentation with accuracy, completeness and compliance to standards.
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Required Competencies- Knowledge, skills, and abilities Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
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REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: - Knowledge of cGMP, GXP, GAMP, SDLC regulations, including CFR part , computer systems validation requirements and good documentation practices.
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Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Celgene standards. Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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Completes all qualification and validation documentation with accuracy, completeness and. Immediate need for a talented Equipment Validation Engineer. Develops validation/qualification deliverables such as Validation Plans, Requirements.
$70 - $77 an hourExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards. Job Title : Validation Engineer. Supports the execution of equipment qualifications and validation protocols.
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Completes all qualification and validation documentation with accuracy, completeness and compliance to Client standards. The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers.
$79 - $81 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Receive and review revisions to USP, EP, JP, FDA regulatory guidelines.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP, GXP, GAMP, and SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices. Provides technical support and guidance on equipment and computer systems qualification and validation issues.
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Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP's, specifications, traceability matrices, thermal mapping documents, and design documentation.
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Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs.
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Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers.
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Assist with the management and development of Hardware and Software Design Submittals, Installation drawings, Sequence of Operations and Commissioning and/or Validation Documentation. Responsible for all Project Related and Customer Required Documentation, to include at a minimum; Submittals, RFI’s, Schedule, Safety Compliance, Commissioning and/or Validation.
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