Senior Validation Manager – Pharma Quality & Growth

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

Benefits offered by this job

Annual bonus

401(k) match

Paid time off

Personal days

Holidays

Health benefits

Discount program

Wellbeing rewards

Career growth

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio seeks a Sr. Validation Manager to lead the Validation Master Plan (VMP) and manage qualifications and re-qualifications. You will review URS, IQ, OQ, PQ, and related docs to ensure CGMP compliance and product quality.

Coordinate with Operations, Engineering, Quality Control and QA, maintain validation records, and support FAT/SAT/commissioning while upholding regulatory requirements.

Qualifications

• 810 years of validation experience in the pharmaceutical or other GMP-regulated industry.
• Experience with aseptic processes preferred.
• Bachelors Degree in engineering, science or equivalent with related work experience.

Responsibilities

• Coordinate validation planning, scheduling, and resource needs across departments.
• Review URS and validation protocols (IQ, OQ, PQ).
• Support FAT, SAT, and commissioning protocols with Engineering.
• Ensure CGMP compliance and proper documentation practices.
• Assist in change controls and problem-solving to protect validated state.
• Maintain equipment qualification and calibration records.
• Ensure regulatory compliance (21 CFR parts 210/211; FDA/OSHA).

Education

Bachelors Degree in engineering, science or equivalent

Tools

Microsoft Project

Trackwise

AMMS

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio seeks a Sr. Validation Manager to lead the Validation Master Plan (VMP) and manage qualifications and re-qualifications. You will review URS, IQ, OQ, PQ, and related docs to ensure CGMP compliance and product quality.

Coordinate with Operations, Engineering, Quality Control and QA, maintain validation records, and support FAT/SAT/commissioning while upholding regulatory requirements.