Validation Engineer

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 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 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.

Preferred Certifications (Nice to Have):

• Six Sigma Green/Black Belt
• Certified Quality Engineer (CQE)
• ISO 13485 Lead Auditor
• PMP (Project Management Professional) Certification