Senior Validation Specialist
3 days ago
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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