{"id":2905173,"url":"https://alion.io/job/hikma-validation-engineer","title":"Validation Engineer","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":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-18T19:03:45Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-22T14:09:27Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Job Title: Equipment Validation Engineer\nLocation: Bedford, Ohio\nJob Type: Full-Time\nSummary\nThe Equipment Validation Engineer III plays a key role in supporting a sterile pharmaceutical manufacturing facility through the qualification and lifecycle management of manufacturing equipment, utilities, and associated systems. This position leads equipment qualification and change-based revalidation activities, supports manufacturing investigations, and collaborates with Operations, Engineering, Maintenance, Quality, and Regulatory functions to ensure compliance with cGMP requirements.\nThe successful candidate will serve as a technical lead for validation projects of moderate to high complexity, providing expertise in risk-based validation strategies, equipment qualification, and continuous process improvement. This role offers significant exposure to new equipment implementation, regulatory inspections, and cross-functional project teams supporting commercial pharmaceutical manufacturing.\nWhy Join Our Team?\nOpportunity to lead high-impact validation projects in a sterile pharmaceutical manufacturing environment.\nExposure to equipment implementation, capital projects, and advanced manufacturing technologies.\nCollaborative cross-functional environment with Operations, Engineering, Quality, and Regulatory organizations.\nOpportunity to mentor developing engineers and influence site validation strategy.\nDirect contribution to the manufacture of critical pharmaceutical products that impact patient health.\nEssential Duties and Responsibilities\nEquipment Qualification & Validation\nLead equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing manufacturing equipment.\nPerform change assessments and lead requalification activities in support of equipment modifications, process changes, and lifecycle management.\nAuthor, execute, and review validation impact assessments, protocols, test scripts, summary reports, periodic review reports and supporting documentation.\nEnsure validation activities are executed in accordance with applicable cGMP regulations, company procedures, and industry best practices.\nProject Leadership\nServe as validation lead for capital projects, equipment implementation efforts, and cross-functional initiatives.\nPartner with Engineering during equipment design, installation, commissioning, startup, and qualification phases.\nCoordinate qualification activities across Operations, Quality Control, Quality Assurance, Engineering, Maintenance, and Manufacturing Science teams.\nManage multiple validation projects simultaneously while maintaining project timelines and priorities.\nTechnical Support & Continuous Improvement\nSupport manufacturing investigations, deviation assessments, root cause analyses, and CAPA implementation activities related to validated systems.\nParticipate in risk assessments and develop scientifically sound validation approaches.\nIdentify opportunities to improve validation processes, documentation practices, and operational efficiency.\nProvide technical guidance and support for equipment lifecycle management activities.\nCompliance & Regulatory Support\nMaintain validation documentation in a state of audit readiness.\nSupport internal audits, client/customer audits, and regulatory inspections, including FDA and other global regulatory agencies.\nContribute validation documentation and technical justifications for regulatory submissions when required.\nLeadership & Mentoring\nMentor junior validation engineers and provide guidance on validation methodologies, documentation practices, and compliance expectations.\nServe as a technical resource within the Validation organization and across site functions.\nRequired Qualifications\nBachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Mathematics, or related technical discipline.\nMinimum of 4 years of validation, engineering, pharmaceutical manufacturing, or related industry experience.\nWorking knowledge of cGMP regulations and validation principles within regulated manufacturing environments.\nStrong technical writing skills with experience authoring validation protocols and reports.\nDemonstrated ability to independently manage technical projects and collaborate with cross-functional teams.\nStrong verbal and written communication skills.\nPreferred Qualifications\n6+ years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated industries.\nExperience performing equipment qualification activities (IQ/OQ/PQ).\nExperience supporting sterile, aseptic, or parenteral manufacturing operations.\nFamiliarity with GAMP 5 (for computerized systems).\nExperience with risk assessments, change controls, deviations, investigations, and CAPA systems.\nExperience supporting regulatory inspections and customer audits.\nExperience with commissioning and qualification (C&Q) activities for new equipment and facility projects.\nDemonstrated leadership experience in cross-functional project teams.\n\nCompensation:\nBase Salary: $59,900 to $120,450 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.\nPreferred Technical Experienc e\nExperience with one or more of the following is highly desirable:\nCompounding and formulation equipment\nFilling equipment\nLyophilizers\nAutoclaves and sterilization systems\nClean utilities\nCIP/SIP systems\nEnvironmental control or HVAC systems\nRABS and Isolators\nInspection packaging systems\nPhysical Requirements\nAbility to routinely work in manufacturing and laboratory environments.\nAbility to walk throughout the facility and stand for extended periods during qualification and project activities.\nAbility to lift up to 40 lbs occasionally.\nAbility to utilize appropriate personal protective equipment (PPE) as required.\nWork Schedule\nThis position is primarily a first-shift role. Occasional off-shift, weekend, or holiday support may be required to support equipment implementation, qualification activities, manufacturing schedules, and project milestones.","description_format":"text","description_chars":6481,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Generic Drugs","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-20T07:36:52Z"}],"visa":[],"liveness":{"score":75,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.791,"p_room":0.945,"age_days":3,"expected_fill_days":5,"reasons":["conf:2","win:mid"],"computed_at":"2026-10-22T06:10:10Z"},"pay":{"stated_usd_annual":120450,"is_top_pay":false},"html_url":"https://alion.io/job/hikma-validation-engineer","json_url":"https://alion.io/job/hikma-validation-engineer.json","meta":{"generated_at":"2026-10-22T16:59:12Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":17735,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1843927},"rest":"https://alion.io/mcp/rest/get_company?id=1843927"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhikma-validation-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fhikma-validation-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fhikma-validation-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/hikma-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhikma-validation-engineer"}]}