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The Director of Validation will lead the Validation department and ensure compliance with all applicable regulations, guidelines, and industry standards. The Director of Validation will collaborate closely with cross-functional teams, including Quality Assurance, Engineering, Production, and Regu...

As the validation engineer you'll be responsible for writing validation protocols (IQ/OQ) as well as validating large complex automated manufacturing equipment in the Pharma & Life Sciences industries. Presenting the validation results to end customer project teams (QA, validation, project manage...

The Director of Validation will lead the Validation department and ensure compliance with all applicable regulations, guidelines, and industry standards. The Director of Validation will collaborate closely with cross-functional teams, including Quality Assurance, Engineering, Production, and Regu...

Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements. Resume receivedmost of resumes received has computer validation and CSV which manager does not want, ...

Strong expertise on lab system validation process including instrument commissioning/decommissioning, calibration, new lab set up, etc. Having experience writing Validation work products: Master Plans, Risk Assessments, Installation Qualification Protocols, Operational Qualification Protocols, Pe...

Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs. This position has responsibility and authority for:Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, Risk Assessments and Validation Summary Re...

Senior Manager, Computerized Systems Validation & Quality Assurance. This encompasses day-to-day operational management and project leadership with a focus on authoring, review, approval of system validation, infrastructure qualification documentation, and execution of protocols where applicable,...

Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation. Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principle...

Development of test methods for Design V&V, Process Validation, and Production Validation of test methods. Clean room environment experience Experience with Test Method Validation and/or Measurement System Analysis is preferred. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analys...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. Supports the execution of equipment qualifications and validation protocols. Supports calibration, equipment qualification and validation ...

Develop and execute validation protocols, test scripts, and validation plans for computer systems used in the healthcare industry. Maintain accurate and up-to-date validation documentation, including validation reports, change control records, and standard operating procedures. Conduct validation...

Manufacturing System Validation – Pharma (Hybrid, Summit West, NJ). We are looking for a System Validation for our client, a Global Biopharmaceutical Company. You will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized syste...

Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols. Performs validation document generation, program management, and protocol execution activities. Execute validation studies, perform data analysis, ...

Work cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. Innova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation Specialist. As an MSEO Manu...

Maintain and update the Validation Master Plan (VMP) and ensure all validation documentation is accurate and complete. Minimum of 3-5 years of experience in validation within a manufacturing environment, preferably in dietary supplements or pharmaceuticals. Strong understanding of regulatory requ...

Career Opportunity: Step into the Role of Equipment Validation Engineer!. Position: Equipment Validation Engineer. As an Equipment Validation Engineer, you will play a crucial role in implementing and maintaining process/lab equipment critical to our cell therapy operations. You will commission a...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. Supports the execution of equipment qualifications and validation protocols. Supports calibration, equipment qualification and validation ...

The Senior Software Validation Engineer will be a remote role with a reporting structure into Trumbull, Connecticut and will be responsible for providing software design and implementation support for Quality Engineering in New Product Development and Sustaining projects. Provide guidance to Engi...

Develops validation/qualification deliverables such as Validation Plans, Requirements. 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. Knowledge...

KEY RESPONSIBILITIES AND ACTIVITIES Develop Master Validation Plans for communicating commissioning, qualification and validation approach and requirements. Pharmaceuticals, Biotechnology, Medical Devices, Cell & Gene Therapy) Experience working on regulatory and compliance environments · B...

Develops validation/qualification deliverables such as Validation Plans. 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. Knowledge of cGMP, GXP,...

Work cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. Innova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation Specialist. As an MSEO Manu...

We are seeking a Validation Engineer - II for a very important client. ...