Senior Validation Manager - GMP Compliance & Qualification

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

Benefits offered by this job

Annual bonus

401(k) with company match

20 days PTO

3 personal days per year

11 company holidays

Health insurance

Dental & vision coverage

Disability & life insurance

Employee discounts

Wellbeing program

Career growth opportunities

Tuition reimbursement

Paid maternity and parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, OH, is seeking a Sr. Validation Manager to lead validation activities for CGMP-compliant processes and equipment. You will manage VMPs, IQ/OQ/PQ, URS review, and cross-functional coordination across Operations, Engineering, Quality Control and Quality Assurance.

The role requires 8–10 years’ validation experience in pharma, a technical degree, plus strong documentation and problem-solving skills. A robust benefits package is offered.

Qualifications

• 8-10 years of validation experience in the pharmaceutical or GMP industry.
• Bachelor’s Degree in engineering, science or related discipline.
• Experience with aseptic processes preferred.
• Knowledge of Microsoft Project, TrackWise and AMMS preferred.
• Demonstrated ability to communicate effectively.

Responsibilities

• Coordinate validation planning, scheduling and resource needs across departments.
• Review and approve URS, IQ, OQ, PQ, FAT, SAT documents.
• Support change control processes and investigation of deviations.
• Ensure CGMP and regulatory compliance (21 CFR parts 210/211).
• Guide equipment qualification and related documentation activities.

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, OH, is seeking a Sr. Validation Manager to lead validation activities for CGMP-compliant processes and equipment. You will manage VMPs, IQ/OQ/PQ, URS review, and cross-functional coordination across Operations, Engineering, Quality Control and Quality Assurance.

The role requires 8–10 years’ validation experience in pharma, a technical degree, plus strong documentation and problem-solving skills. A robust benefits package is offered.