Darsh Patel
Validation Specialist at PCI Pharma Services | Pharmaceutical Manufacturing | Biomedical and Packaging Engineering
- Role
- Validation Specialist at PCI Pharma Services
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Darsh Patel
With over five years of professional experience, I am currently enhancing pharmaceutical…
Experience
Validation Specialist
Jun 2025 — Present · Philadelphia, PA, US
Represents validation for the qualification and validation of packaging equipment and processes to ensure compliance with regulatory standards and customer expectations. • Execute packaging equipment qualifications, product packaging validations, and cleaning validation activities.• Perform computer system validation activities in accordance with 21 CFR Part 11 and data integrity requirements.• Support Environmental monitoring, facilities/ utilities qualification, and temperature mapping• Participate in internal, customer, and regulatory audits.• Conduct periodic evaluations and gap assessments for requalification needs.• Provide peer reviews for validation protocols and reports.• Ensure timely completion of CAPAs and training assignments.• Contribute to continuous improvement initiatives within the Validation team.
Education
Parsippany Hills High School
High School Diploma
2015 — 2019
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