Equipment Validation Supervisor

Job Title: Equipment Validation SupervisorLocation: Bedford, OhioJob Type: Full-TimeReq ID: 11863About 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, sterilizersHVAC systems and cleanroom equipmentPackaging and inspection systemsEnsure compliance with Annex 1 (sterile manufacturing) where applicable.Regulatory Compliance & QualityEnsure all validation activities comply with:FDA (21 CFR Part 210/211)EU GMP / Annex 1ICH guidelinesMaintain inspection readiness for FDA, MHRA, and other global regulatory audits.Review and approve validation protocols, reports, SOPs, and change controls.Project & Lifecycle ManagementLead validation efforts for:New equipment and facility expansionsTechnology transfers and new product launchesManage 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 CollaborationPartner 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 & ExperienceWe 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 disciplineMaster’s degree preferredExperience5+ years of experience in pharmaceutical validation, preferably in sterile/injectable manufacturingMinimum 1 year in a supervisory or leadership roleExperience working in FDA-inspected facilities Technical ExpertiseDeep knowledge of validation lifecycle (IQ/OQ/PQ) and risk-based validation approachesStrong experience with aseptic processing and sterile equipment validationFamiliarity with:GAMP 5 (for computerized systems)Cleaning validation and process validation (preferred)Understanding of calibration, maintenance, and asset lifecycle systemsSoft SkillsStrong leadership and team development skillsExcellent communication and stakeholder managementHigh attention to detail and strong documentation skillsAbility to manage multiple priorities in a fast-paced GMP environmentPreferred QualificationsExperience in injectables or high-volume generics manufacturingLean Six Sigma certificationExperience with electronic validation systems and QMS platforms (e.g., TrackWise, Veeva)What We Offer*:Annual performance bonus, commission, and share potentialAuto 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 contributeA generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries3 personal days (prorated based on hire date)11 company paid holidaysComprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefitsEmployee discount programWellbeing rewards programSafety and Quality is a top organizational priorityCareer advancement and growth opportunitiesTuition reimbursementPaid 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. 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.