{"id":2905249,"url":"https://alion.io/job/hikma-equipment-validation-supervisor","title":"Equipment Validation Supervisor","company":{"id":1843927,"name":"Hikma Pharmaceuticals","domain":"hikma.com","url":"https://alion.io/company/hikma","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":59900,"max":120450,"currency":"USD","period":"year","gross":null,"usd_annual":120450},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"Veeva","optional":true}],"status":"live","first_seen_at":"2026-09-01T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-24T01:08:35Z","board_verified":true,"closed_at":null,"days_open":53,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":53},"description":"Job Title: Equipment Validation Supervisor\nLocation: Bedford, Ohio\nJob Type: Full-Time\nAbout Us:\nAs 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.\nDescription:\nWe 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.\nThe 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.\nKey Responsibilities:\nLeadership & Team Management\nLead, coach, and develop a team of validation engineers/specialists.\nAllocate resources and manage validation priorities aligned with production and project timelines.\nFoster a culture of compliance, quality, and continuous improvement.\nEquipment Qualification & Validation\nOversee and approve execution of:Installation Qualification (IQ)\nOperational Qualification (OQ)\nPerformance Qualification (PQ)\n\nEnsure validation of critical GMP equipment, including:Filling lines, autoclaves, lyophilizers, sterilizers\nHVAC systems and cleanroom equipment\nPackaging and inspection systems\n\nEnsure compliance with Annex 1 (sterile manufacturing) where applicable.\nRegulatory Compliance & Quality\nEnsure all validation activities comply with:\nFDA (21 CFR Part 210/211)\nEU GMP / Annex 1\nICH guidelines\nMaintain inspection readiness for FDA, MHRA, and other global regulatory audits.\nReview and approve validation protocols, reports, SOPs, and change controls.\nProject & Lifecycle Management\nLead validation efforts for:\nNew equipment and facility expansions\nTechnology transfers and new product launches\nManage equipment lifecycle, including periodic review and requalification.\nCollaborate with Engineering and Manufacturing on commissioning and qualification (C&Q).\nDeviation, CAPA & Risk Management\nOversee investigations related to validation failures or deviations.\nLead root cause analysis and ensure timely implementation of CAPA.\nConduct risk assessments using tools like FMEA and support risk-based validation strategies.\nCross-functional Collaboration\nPartner with QA, Engineering, MS&T, Regulatory Affairs, and Operations teams.\nSupport process improvements and operational efficiency initiatives.\nProvide technical expertise during audits, inspections, and regulatory submissions.\nQualifications & Experience\nWe 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:\nEducation\nBachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related discipline\nMaster’s degree preferred\nExperience\n5+ years of experience in pharmaceutical validation, preferably in sterile/injectable manufacturing\nMinimum 1 year in a supervisory or leadership role\nExperience working in FDA-inspected facilities\nTechnical Expertise\nDeep knowledge of validation lifecycle (IQ/OQ/PQ) and risk-based validation approaches\nStrong experience with aseptic processing and sterile equipment validation\nFamiliarity with:GAMP 5 (for computerized systems)\nCleaning validation and process validation (preferred)\n\nUnderstanding of calibration, maintenance, and asset lifecycle systems\nSoft Skills\nStrong leadership and team development skills\nExcellent communication and stakeholder management\nHigh attention to detail and strong documentation skills\nAbility to manage multiple priorities in a fast-paced GMP environment\nPreferred Qualifications\nExperience in injectables or high-volume generics manufacturing\nLean Six Sigma certification\nExperience with electronic validation systems and QMS platforms (e.g., TrackWise, Veeva)\nCompensation:\nBase Salary: $59,900.00 to $120,450.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.\nWhat We Offer*:\nAnnual performance bonus, commission, and share potential\nAuto 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\nA generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries\n3 personal days (prorated based on hire date)\n11 company paid holidays\nComprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits\nEmployee discount program\nWellbeing rewards program\nSafety and Quality is a top organizational priority\nCareer advancement and growth opportunities\nTuition reimbursement\nPaid maternity and parental leave\n*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.\nRecruiters:\nPlease 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.\nEqual Opportunity Employer:\nHikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. 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