Description

You will lead validation operations for sterile injectable pharmaceutical manufacturing in Decatur, IL.

This role is on-site.

Responsibilities

• Develop and update Validation Master Plans (VMP/CVMP).
• Create and maintain essential documentation including URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs.
• Execute validation protocols for autoclaves, depyrogenation tunnels, stability chambers, and cleaning processes.
• Oversee validation of analytical instruments, facilities, and related systems.
• Ensure strict compliance with cGMP, FDA guidelines, ISPE, GAMP, and FDA CFR Part 11.

Required Skills

• Over 25 years of professional experience in pharmaceutical validation.
• At least 5 years of management experience in validation.
• Extensive experience with sterile injectable products.
• Hands-on expertise in VMP/CVMP development.
• Proficiency with URSs, FDSs, and DOEs.
• Deep knowledge of cGMP standards and FDA guidelines.
• Working knowledge of ISPE and GAMP methodologies.
• Strong understanding of FDA CFR Part 11 compliance.
• Experience validating autoclaves and depyrogenation tunnels.

Preferred Skills

• Any Graduate education.

Key Skills

Education

Any Graduate