About this opportunity
Hikma Pharmaceuticals lists this Equipment Validation Supervisor opportunity in bedford, Ohio. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Title: Equipment Validation Supervisor
Location: Bedford, Ohio
Job Type: Full-Time
Req ID: 11863
Check out the role overview below If you are confident you have got the right skills and experience, apply today.
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.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. xzgxqkn
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.
Worksite address
bedford, OH, 44146, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.