Job Title: Senior Validation Specialist - 100% Onsite

Location : Birmingham, AL

Duration : 10-month contract (potential extension)

Schedule : Monday–Friday, 8:00 AM–5:00 PM (40 hours/week)

Pay : $50 - $65/hour

Job Description:

The Senior Validation Specialist will develop and execute validation protocols, analyze data, and prepare summary reports. This role involves acting as a subject matter expert on sterilization processes and aseptic process simulations and coordinating with other departments to complete validation tasks.

Key Responsibilities:

• Develop and execute validation protocols and pre-approved test cases.
• Prepare summary reports on executed protocols.
• Provide expertise on sterilization processes (autoclaves, SIP, VHP decontamination) and aseptic process simulation.
• Peer review protocols and data.
• Coordinate with QC, production, and other departments as needed.
• Review and update validation procedures and policies.

Qualifications and Expertise:

• Bachelor’s in Engineering, Chemistry, or Microbiology.
• 5+ years of experience in one or more of the following:
• Aseptic process simulations (Media Fills), Steam sterilization (autoclave, SIP), VHP decontamination validation, Cleaning validation for drug manufacturing equipment, and Environmental monitoring performance qualification.
• Familiar with 21 CFR Part 211/210, FDA inspections, Eudralex Annex 1, ISPE cleanroom guidelines, and IPEC cleaning validation.
• Experience with sterile injectable manufacturing preferred.