Job 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 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 Management Develop and execute Installation Qualification IQ Operational Qualification OQ and Performance Qualification PQ protocols for new and existing manufacturing processes Develop and execute Test 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 Mitigation Review 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 Evaluation Conduct 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 Support Work closely with Manufacturing R D Regulatory Affairs and Quality Assurance teams Support Design Transfer Process Optimization and Cost Reduction initiatives Provide technical guidance and training on validation principles and quality tools Participate in project teams for sustaining engineering and product lifecycle management Manage cross-functional activities and coordinate with global teams Required Qualifications Bachelor s Degree BE BTech in Mechanical Electrical Electronics or related engineering discipline Master s degree will be an added advantage Experience Level Senior 8-10 Years 8-10 years of experience in manufacturing process validation and quality engineering in the medical device industry Awareness of 21 CFR 820 ISO 13485 GMP and QSR Experience in sustaining engineering product lifecycle management and design transfer Required Skills Competencies Process Validation Expertise IQ OQ PQ TMV re-validation change management Quality Tools FMEA RCA 5 Whys Fishbone Diagram Control Plans Statistical Analysis Minitab SPC DOE capability studies Documentation Compliance Technical writing audit readiness regulatory documentation Strong documentation skills with experience in regulated industries medical device pharma aerospace Manufacturing knowledge Knowledge of special processes in process validation in the Medical device industry Design for manufacturing assembly and testability Familiarity with DMR translation to production processes and R D activities Proven experience in special process management and manufacturing operations Strong understanding of special Process like Brazing Injection Molding Plastics Extrusion Adhesive Bonding glueing Plastic Bonding ultrasonic welding thermal bonding Annealing and heat treating Welding laser welding fuse welding ultrasonic welding Soldering wave soldering manual soldering reflow soldering Casting Plating will be added advantage Problem Solving Structured approach to troubleshooting and continual improvement Project Management Ability to manage multiple projects and meet deadlines Communication Strong interpersonal and cross-functional collaboration skills Excellent communication both verbal and written Prior process validation experience is required Ability to work independently and manage multiple projects simultaneously Behavioural Competencies Disciplined team worker ability to work independently Hands-on mentality with the ability to work on-site as required Ability to present ideas and to convince project team members Quality mindset in analysis and documentation Be structured and self-organized Positive can do attitude Preferred Certifications Nice to Have Six Sigma Green Belt Black Belt Certified Quality Engineer CQE ISO 13485 Lead Auditor PMP Project Management Professional What We Offer Chance to work on cutting-edge medical technologies that impact lives globally Collaborative and inclusive work culture Continuous learning and career development opportunities Competitive compensation and benefits package A chance to be part of a purpose-driven organization Job Types Full-time Permanent Contractual Temporary Contract length 12 months Pay 800 000 00 - 1 000 000 00 per year Ability to commute relocate Pune Maharashtra Reliably commute or planning to relocate before starting work Preferred Application Question s Experience with IQ OQ and PQ validations in a manufacturing environment Education Bachelor s Preferred Experience ISO 13485 FDA 21 CFR 820 8 years Preferred Reviewing or Creating validation documentation 8 years Preferred validation within the medical device industry 8 years Preferred Location Pune Maharashtra Required Work Location In person

📌 Process Validation Engineer (Maharashtra)
🏢 Akidev
📍 Maharashtra