Validation Supervisor

RXinsider LTD.; Bedford (OH); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

401(k) matching

PTO 20 days

Health benefits

Tuition reimbursement

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio is seeking an Equipment Validation Supervisor to lead qualification and validation activities across manufacturing and laboratory systems, with a focus on sterile/injectable environments.

You will manage a team of validation engineers, oversee IQ/OQ/PQ, ensure compliance with FDA, EU GMP, and ICH guidelines, and drive continuous improvement through risk-based validation and CAPA processes.

Qualifications

• 5+ years in pharmaceutical validation, sterile/injectable preferred.
• Bachelor’s degree in Engineering or Life Sciences.
• Supervisory or leadership experience required.
• Experience with FDA inspections and GMP standards.

Responsibilities

• Lead IQ/OQ/PQ activities for critical equipment.
• Coach and develop a validation team.
• Ensure regulatory compliance and audit readiness.
• Collaborate with QA, Engineering, and Operations.

Skills

Leadership

Validation expertise

Regulatory knowledge

Project management

Risk assessment

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or related field

Master’s degree preferred

Tools

TrackWise

Veeva

GAMP 5

Job description

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.

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)

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.