Manufacturing Equipment Validation Supervisor

Overview

Job Title: Equipment Validation Supervisor

Location: Bedford, Ohio

Job Type: Full-Time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Equipment Validation Supervisor to join our team. In this role, you will be responsible for leading equipment qualification and validation activities across manufacturing and laboratory systems, with a strong focus on sterile and injectable product environments.

This role ensures compliance with FDA, cGMP, and global regulatory standards, while supporting Hikma’s commitment to high-quality, accessible medicines.

The Supervisor will manage a team of validation professionals, oversee IQ/OQ/PQ activities, and collaborate cross-functionally to support new product introductions, capacity expansion, and continuous improvement initiatives.

• Lead, coach, and develop a team of validation engineers/specialists.
• Allocate resources and manage validation priorities aligned with production and project timelines.
• Foster a culture of compliance, quality, and continuous improvement.

• Oversee and approve execution of:
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Ensure validation of critical GMP equipment
  , including:
• HVAC systems and cleanroom equipment
• Packaging and inspection systems
• Ensure compliance with Annex 1 (sterile manufacturing) where applicable.

• Ensure all validation activities comply with:
• FDA (21 CFR Part 210/211)
• EU GMP / Annex 1
• ICH guidelines
• Maintain inspection readiness for FDA, MHRA, and other global regulatory audits.
• Review and approve validation protocols, reports, SOPs, and change controls.

• Lead validation efforts for:
• New equipment and facility expansions
• Technology transfers and new product launches
• Manage equipment lifecycle, including periodic review and requalification
  .
• Collaborate with Engineering and Manufacturing on commissioning and qualification (C&Q).
• Oversee investigations related to validation failures or deviations.
• Lead root cause analysis and ensure timely implementation of CAPA.
• Conduct risk assessments using tools like FMEA and support risk-based validation strategies.

• Partner with QA, Engineering, MS&T, Regulatory Affairs, and Operations teams.
• Support process improvements and operational efficiency initiatives.
• Provide technical expertise during audits, inspections, and regulatory submissions.

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

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

• 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