Senior Validation Manager – GMP Validation Lead

RXinsider LTD.; Bedford (OH); On-site; USD 93,000 - 158,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with company match

20 days PTO

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Validation Manager in Bedford, Ohio, to lead the Validation Master Plan and oversee qualification activities for equipment, facilities, and utilities in a cGMP environment.

You will review URS, IQ/OQ/PQ, and related documents, coordinate with Operations, Engineering, Quality Control and QA, and ensure all validation activities comply with regulatory standards and internal policies.

Qualifications

• 8-10 years of validation experience in the pharmaceutical or GMP-regulated industry.
• Experience with aseptic processes is preferred
• Bachelor’s Degree in engineering, science or another discipline with equivalent work experience
• Knowledge of Microsoft Project, Trackwise, AMMS preferred
• Demonstrated ability to communicate effectively with others

Responsibilities

• Coordinate validation planning and scheduling with multiple departments.
• Review and approve URS, IQ, OQ, PQ, FAT, SAT, and related docs.
• Ensure CGMP compliance and proper documentation practices.
• Maintain and calibrate equipment used for qualification.
• Support change control and problem-solving to protect validated state.
• Oversee cross-functional coordination for validation projects.

Skills

Validation experience

GMP knowledge

Communication skills

Education

Bachelor's Degree in engineering or science

Tools

Microsoft Project

Trackwise

AMMS

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Validation Manager in Bedford, Ohio, to lead the Validation Master Plan and oversee qualification activities for equipment, facilities, and utilities in a cGMP environment.

You will review URS, IQ/OQ/PQ, and related documents, coordinate with Operations, Engineering, Quality Control and QA, and ensure all validation activities comply with regulatory standards and internal policies.