Validation Engineer
2 days ago
Job Title: Process Validation EngineerLocation: Pune, IndiaJob Type: 1 Year contract (On-site)Position Summary:The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers are executed in compliance with applicable regulations , ISO 13485 and Quality Management System (QMS) requirements. The engineer will lead validation activities, support cross-functional teams, and drive continuous improvement initiatives to ensure product quality and patient safety.The person in this role is accountable for ensuring that all manufacturing and test processes for medical devices are validated, maintained, and improved in compliance with applicable regulatory standards (such as FDA 21 CFR Part 820, ISO 13485, and Philips QMS).Key Responsibilities:1. Process Validation & Lifecycle ManagementDevelop and execute Installation Qualification (IQ) , Operational Qualification (OQ) , and Performance Qualification (PQ), protocols for new and existing manufacturing processes.Develop and execute T est Method Validation (TMV) protocols for new and existing test methods.Assess quality and effectiveness of process validation based on review of validation documentation submitted by suppliers.Prior verification or validation experience is required. Ability to guide and perform process validation (PV) related activities.Maintain a validated state of processes through periodic reviews, re-validation, and change control.Author and review validation documentation including protocols, reports, and risk assessments.Ensure validation activities align with FDA 21 CFR Part 820 , ISO 13485 , ISO 14971 and Philips QMS.2. Quality Engineering & Risk MitigationReview, conduct and lead Process FMEAs , Design FMEAs , and Control Plans .Perform Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA) .Support internal and external audits, including FDA inspections and Notified Body audits.Validate supplier processes and ensure robust controls.Capable of solving complex mfg. process problem.Execute problem solving related to Manufacturing processes, tools and equipment.Responsible for participating and representing SQE organization in APQP/PDLM process.Applies lean manufacturing principles.3. Data Analysis & Statistical EvaluationConduct Gauge R&R, ANOVA, sample size determination, variance analysis, DOE, regression, and other statistical analyses to improve process reliability and quality.Use statistical tools (e.g., Minitab , SPC , DOE ) to analyze process capability, stability, and performance.Interpret data to identify trends, deviations, and opportunities for improvement.Develop and monitor Key Process Indicators (KPIs) and validation metrics.4. Cross-Functional Collaboration & Project SupportWork closely with Manufacturing , R&D , Regulatory Affairs , and Quality Assurance teams.Support Design
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Validation Engineer
2 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation Engineer Location: Pune, India Job Type: 1 Year contract (On-site) Position Summary: The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers...
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Validation Engineer
2 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation Engineer Location: Pune, India Job Type: 1 Year contract (On-site) Position Summary: The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers...
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Validation Engineer
4 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation Engineer Location: Pune, India Job Type: 1 Year contract (On-site) Position Summary: The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers...
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Validation Engineer
2 days ago
pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation EngineerLocation: Pune, IndiaJob Type: 1 Year contract (On-site)Position Summary:The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers are...
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Validation Engineer
2 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation EngineerLocation: Pune, IndiaJob Type: 1 Year contract (On-site)Position Summary:The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers are...
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Validation Engineer
2 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation EngineerLocation: Pune, IndiaJob Type: 1 Year contract (On-site)Position Summary:The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers are...
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Validation Engineer
4 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation EngineerLocation: Pune, IndiaJob Type: 1 Year contract (On-site)Position Summary:The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers are...
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Validation engineer
2 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation EngineerLocation: Pune, IndiaJob Type: 1 Year contract (On-site)Position Summary:The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers are...
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Validation Engineer
2 days ago
Pune, India Whatjobs IN C2 Full timeJob Title: Process Validation Engineer Location: Pune, India Job Type: 1 Year contract (On-site) Position Summary: The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers...
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Validation Engineer
3 days ago
Pune, India Fusion Life Sciences Technologies LLC Full timeJob Title: Process Validation EngineerLocation: Pune, IndiaJob Type: 1 Year contract (On-site)Position Summary:The Process Validation Engineer plays a critical role in maintaining and improving validated manufacturing processes for medical devices. This role is primarily supplier-facing and ensures that all process changes, improvements, and transfers are...
