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Key Responsibilities: Develop, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for downstream processing equipment. Coordinate FAT/SAT execution and documentation with vendors and engineering…
The Validation Engineer/ Specialist will be responsible of all validation activities for the assigned project. This project include the validation of multiple autoclaves and Temperature controllers. Validation Scope…
We are seeking a highly motivated Validation Engineer to support validation activities within regulated industries such as Pharmaceuticals, Biotechnology, Medical Devices, Chemicals, or Food Manufacturing . The…
Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade , to support a biologics manufacturing facility. The role will be responsible for…
Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies. Oversees and reviews validation area…
Senior Validation Specialist – Utilities and Facilities Position Summary The Senior Validation Specialist for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility…
Support Quality Assurance program: Non Conformances Review and approve product MPs. Approve validation protocols and reports for manufacturing processes. Approve Environmental Characterization reports. Lead…
Development and execution of Laboratory Equipment Validation. Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Execution of…
Reporting to the Senior Quality Assurance Manager, this position is responsible for Quality oversight of the local validation program which includes Facilities, Utilities, Manufacturing equipment and Computer Systems.…
The Validation Engineer will support the Cold Chain Shipping Validation (temperature mapping, product stability studies, and/or simulated distribution). Work with multi-discipline engineering teams, as well as other…
Document Control / Data Management Will verify Commissioning, Qualification and Validation Documents as needed. Will Generate data management metrics. Will work with Excel and pivot tables. Administrative and Non…
Accountable to provide Quality oversight of FP Technologies method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments…
Expertise in “Risk Based Approach” for Commissioning and Qualification practices Planning and Integration of Commissioning and Qualification activities in medical device manufacturing (Class II preferred) Risk…
Provide support for the CSV lifecycle This position will work with Computer System Validation (CSV), IQ, OQ, GAMP5 CSV and will be responsible for: Develop SDLC documents for Manufacturing Equipment including CSV…
1. High degree experience in Rockwell Automation platforms (Controllogix PLCs, Factory Talk HMIs, communication protocols) is required. 2. Siemens systems knowledge preferred. 3. High degree knowledge and experience in…
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