Equipment Validation Supervisor

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 59,900 - 120,450; Full time

Benefits offered by this job

Annual performance bonus

401(k) plan with company match

Generous paid time off

Job summary

Hikma Pharmaceuticals in Bedford, Ohio is looking for an experienced Equipment Validation Supervisor. This role will lead the qualification and validation activities for sterile and injectable manufacturing environments, ensuring compliance with FDA and global standards.

The ideal candidate should have over 5 years of validation experience and be skilled in managing a team. The position offers a full-time opportunity with competitive compensation and comprehensive benefits.

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.

Responsibilities

• Lead and develop a team of validation engineers.
• Ensure compliance with FDA and global regulatory standards.
• Oversee qualification and validation activities for sterile manufacturing.

Skills

Leadership and team development

Excellent communication

Attention to detail

Education

Bachelor’s degree in Engineering or related discipline

Master’s degree preferred

Tools

TrackWise

Veeva

Job description

Job Title: Equipment Validation Supervisor

Location: Bedford, Ohio

Job Type: Full-Time

About Us

Hikma Pharmaceuticals USA Inc. is a developer, manufacturer, and supplier of essential medicines, committed to bringing better health to millions worldwide. With 32 manufacturing plants, eight R&D centers, and 9,500+ employees, we provide high‑quality generic, specialty, and branded products across the globe.

Job Overview

We are seeking a talented and motivated Equipment Validation Supervisor to lead qualification and validation activities for sterile and injectable manufacturing environments, ensuring compliance with FDA, cGMP, and global regulatory standards.

Key Responsibilities

Leadership & Team Management

• 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.

Equipment Qualification & Validation

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

Regulatory Compliance & Quality

• 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.

Project & Lifecycle Management

• 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).

Deviation, CAPA & Risk Management

• 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.

Cross‑functional Collaboration

• 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.

Qualifications & Experience

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:

Education

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

Experience

• 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

Technical Expertise

• 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

Soft Skills

• Strong leadership and team development skills
• Excellent communication and stakeholder management
• High attention to detail and strong documentation skills
• Ability to manage multiple priorities in a fast‑paced GMP environment

Preferred Qualifications

• Experience in injectables or high‑volume generics manufacturing
• Lean Six Sigma certification
• Experience with electronic validation systems and QMS platforms (e.g., TrackWise, Veeva)

Compensation

Base Salary: $59,900.00 to $120,450.00 annually. Compensation will be determined during the interview process and will vary based on factors such as location, experience, and market.

What We Offer*

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma‑sponsored 401(k) program at a pre‑tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.