Senior Validation Specialist

3 days ago


Pune, Maharashtra, India DD Enterprises Full time

We are seeking a Senior Validation Specialist to join DD Enterprises, a dynamic organization that values excellence and innovation. This role is an exciting opportunity for a seasoned professional to lead the way in validation processes and regulatory compliance.

**Job Summary**

The successful candidate will have extensive experience in validation of biopharma and sterile process equipment, with a strong knowledge of regulatory requirements, including ISPE C&Q Vol 5, GAMP 5, 21 CFR Part 11, EU Annex 11, and other PIC/ICH guidelines and GxP.

**Key Responsibilities:**

  • Lead the development and implementation of validation strategies and plans.
  • Review and approve documentation, including URS, DQ, FAT-IOQ/SAT-IOQ.
  • Collaborate with cross-functional teams to ensure effective execution of FAT activities.
  • Prepare, execute, and customer-approve qualification documents.

**Requirements:**

  • Bachelor's degree in Mechanical/Instrumentation Engineering or a related field.
  • 8-10 years of experience in validation of biopharma and sterile process equipment.
  • Strong knowledge of regulatory standards, including GMP, FDA regulations, ISO Standards.
  • Proficiency in various validation methodologies and documentation.

**Salary:** $120,000 - $150,000 per annum, depending on experience.

**Location:** Flexible remote work options available. Candidates must be willing to relocate to our headquarters upon hire.



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