Process Validation Engineer

PROCESS VALIDATION

Exp : 4 To 15 Years

Salary : As per experience

ABOUT IZIEL HEALTHCARE:

IZiel Healthcare is an Engineering & Regulatory service provider working with global medical device manufacturers. We partner with customers to support them with all aspects of the Product Life Cycle.

Employees are the key to success in our organization. We value our engineers and their skills in furthering the cause of helping lives. Thorough leadership, robust work planning methodology, and exceptional customer service are the key enablers of our success.

POSITION DESCRIPTION:

Senior PV Engineer Process Validation

POSITION RESPONSIBILITIES:

• Lead and execute process validation (IQ/OQ/PQ), cleaning validation, and equipment qualification activities.
• Develop and review validation protocols and reports in accordance with regulatory and internal quality requirements.
• Define validation strategy for manufacturing processes, including risk-based approaches per ISO 14971.
• Work closely with cross-functional teams (RA, QA, Manufacturing, and Engineering) to ensure validation activities are planned and executed on time.
• Review and interpret data from validation studies, applying basic statistical methods where necessary.
• Ensure documentation is audit-ready and compliant with 21 CFR Part 820, ISO 13485, and other applicable standards.
• Support development and execution of test methods and acceptance criteria.
• Maintain validation master plans, equipment qualification records, and change control documentation.
• Assist in addressing non-conformances and implementing corrective/preventive actions (CAPA) related to validation findings.
• Stay updated on global regulatory requirements and validation best practices.

DESIRED/PREFERRED QUALIFICATIONS:

• Bachelors degree in Engineering or related field with

  4+ years

  of experience in process validation in the medical device industry.
• In-depth understanding of

  21 CFR Part 820

  ,

  ISO 13485

  ,

  ISO 14971

  , and

  FDA/CE validation requirements

  .
• Experience with validation of manufacturing processes such as injection molding, packaging, sterilization, etc.
• Knowledge of statistical tools and software (e.g., Minitab) for data analysis.
• Strong technical writing and documentation skills.
• Excellent communication and interpersonal skills.
• Detail-oriented and highly organized with the ability to manage multiple validation projects.
• Willingness to travel, if required.