Validation Specialist

Mindlance; Collegeville (PA); On-site; USD 65,000 - 85,000; Full time

Job summary

A national recruiting company is seeking a candidate for a role involving validation protocols within the pharmaceutical industry. Responsibilities include writing validation protocols, executing them in collaboration with support groups, and preparing regulatory documentation. Ideal applicants should have a Bachelor's degree in a scientific field and proven experience in microbiological testing validation. Strong initiative and a solid understanding of validation principles and FDA regulations are essential for success in this role.

Qualifications

• Bachelor's degree in a relevant field such as Biology, Microbiology, or Engineering.
• Proven experience in validation within the pharmaceutical industry.
• Strong initiative and understanding of validation principles and FDA requirements.

Responsibilities

• Write and coordinate validation protocols and reports.
• Execute validation protocols with support groups.
• Prepare documentation for regulatory filings.

Skills

Validation protocols writing

Microbiological testing validation

GMP laboratory operations

Knowledge of FDA regulations

Understanding of validation principles

Education

Bachelor’s degree in a scientific or technical discipline

Job description

Overview

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com.

Responsibilities

• Writing validation protocols, coordinating and/or performing validation and writing validation reports to support validation of HVLD, ensuring that all test methods meet the USP and regulatory requirements
• Execution of validation protocols in coordination with other support groups such as GMS, Process validation, and Microbiology department
• Prepare documentation for regulatory filing

Qualifications

• Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Microbiology, Engineering, etc)
• Experience in pharmaceutical industry with microbiological testing validation
• Experience with GMP laboratory operations and FDA regulations
• Possesses an understanding and experience of validation principles with good knowledge of Industry Standards and current validation and method development requirements
• A strong sense of initiative is required for this position

Additional Information

All your information will be kept confidential according to EEO guidelines.