Process 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 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:

Opportunity 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