Senior Validation Manager: cGMP Compliance & QA

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 93,000 - 158,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) matching program

20 days PTO plus milestones

Personal days

Comprehensive benefits (health, dental

Vision, disability, life insurance

Employee discount program

Career advancement opportunities

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. seeks a Sr. Validation Manager to lead the Validation Master Plan (VMP) and manage qualifications for process and facility systems in a CGMP environment.

The role requires 8–10 years of pharma validation experience, a engineering or science degree, strong documentation practices, and cross‑functional collaboration with Operations, Engineering, and Quality teams.

Qualifications

• 8–10 years of validation experience in 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 and maintain validation responsibilities including planning, scheduling, and resource requirements.
• Review and approve URS, IQ, OQ, PQ, FAT, SAT, and commissioning protocols.
• Support change control processes and equipment troubleshooting to maintain validated state.
• Ensure compliance with cgmp and regulatory requirements and current documentation practices.
• Collaborate with Operations, Engineering, Quality Control and Quality Assurance.

Skills

Validation experience

Aseptic processes

Communication skills

Microsoft Project

Trackwise

AMMS

Education

Bachelor’s Degree in engineering, science, or equivalent

Tools

Microsoft Project

Trackwise

AMMS

Job description

Hikma Pharmaceuticals USA Inc. seeks a Sr. Validation Manager to lead the Validation Master Plan (VMP) and manage qualifications for process and facility systems in a CGMP environment.

The role requires 8–10 years of pharma validation experience, a engineering or science degree, strong documentation practices, and cross‑functional collaboration with Operations, Engineering, and Quality teams.