Sterile Equipment Validation Lead

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

PTO 20 days

Personal days

Health insurance

Dental & Vision

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, OH seeks an Equipment Validation Supervisor to lead qualification programs for sterile and injectable manufacturing.

You will manage a team, oversee IQ/OQ/PQ, and ensure compliance with FDA, EU GMP, and global standards while driving CAPA and continuous improvement. You will collaborate with Engineering, Manufacturing, QA, and Regulatory Affairs on new product introductions, capacity expansion, and risk-based validation strategies, with a focus on

Qualifications

• 5+ years of experience in pharmaceutical validation, preferably in sterile/injectable manufacturing.
• Minimum 1 year in a supervisory or leadership role.
• Experience working in FDA-inspected facilities.
• Deep knowledge of validation lifecycle (IQ/OQ/PQ) and risk-based validation approaches.
• Strong experience with aseptic processing and sterile equipment validation.
• Familiarity with GAMP 5 (for computerized systems).
• Cleaning validation and process validation (preferred).
• Understanding of calibration, maintenance, and asset lifecycle systems.

Responsibilities

• Lead validation engineers/specialists and manage resources.
• Oversee and approve execution of IQ/OQ/PQ activities and validation of critical GMP equipment.
• Ensure validation of HVAC systems and cleanroom equipment as applicable.
• Ensure compliance with FDA, EU GMP, and ICH guidelines; maintain inspection readiness.
• Lead validation efforts for new equipment, facility expansions, technology transfers, and launches.
• Manage equipment lifecycle including periodic review and requalification; collaborate on C&Q.
• Oversee investigations related to validation failures or deviations; lead root cause analysis and CAPA.
• Conduct risk assessments using tools like FMEA and support risk-based validation strategies.
• Partner with QA, Engineering, MS&T, Regulatory Affairs, and Operations; support audits and regulatory submissions.

Skills

Leadership

Communication

Documentation

GMP compliance

Project management

Education

Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related discipline

Tools

TrackWise

Veeva

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, OH seeks an Equipment Validation Supervisor to lead qualification programs for sterile and injectable manufacturing.

You will manage a team, oversee IQ/OQ/PQ, and ensure compliance with FDA, EU GMP, and global standards while driving CAPA and continuous improvement. You will collaborate with Engineering, Manufacturing, QA, and Regulatory Affairs on new product introductions, capacity expansion, and risk-based validation strategies, with a focus on