{"id":1683610,"url":"https://alion.io/job/kashiv-biosciences-validation-engineer-iii","title":"Validation Engineer III","company":{"id":3854512,"name":"Kashiv Biosciences","domain":"kashivbiosciences.com","url":"https://alion.io/company/kashiv-biosciences","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Piscataway, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":67000,"max_usd":124000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3384},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-08-08T18:29:40Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-13T10:23:29Z","board_verified":true,"closed_at":null,"days_open":65,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":65},"description":"Description\nCompany Overview\nCreating a Healthier World through Accessible Biologics:\nKashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.\nPosition Summary\nThe Validation Engineer III is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This employee will be responsible for developing, testing, modifying, and creating solutions to technical problems.\nEssential Duties & Responsibilities:\nDraft and implement Quality System documentation including SOPs and Traceability Matrix designed to establish good validation practices within the organization.\nAuthor URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.\nCoordinate all validation activities with vendors, cross functional team and assemble results, and draft validation reports.\nServe as the validation representative during FDA, customer, and internal audits.\nProvide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.\nLead or participate in deviation/CAPA investigations related to qualification failures, equipment malfunctions, or out-of-specification results, applying root cause analysis methodologies (5-Whys, Ishikawa, Fault Tree).\nPrepare, Review and approve vendor qualification documentation, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) protocols and execution reports.\nDevelop and maintain the site Validation Master Plan (VMP), including validation impact assessments, criticality ranking, and lifecycle change management for validated systems.\nProvide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.\nMaintain validation status tracking dashboards and periodic system health reviews to ensure all validated systems remain in a continuous state of inspection readiness.\nExecute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.\nComply with all regulatory, corporate, and Quality System policies.\nRequirements\nPosition Requirements and Qualifications\nMinimum Qualifications:\nEducation:\n·Degree in engineering / Pharmaceuticals or another relevant discipline.\nExperience:\n8+ years of experience working within a medical device environment or other FDA-regulated environments. \nExperience with Biological products is highly desirable.\n Preferred Qualifications:\nSPECIALIZED KNOWLEDGE AND SKILLS:\nExperience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), Understanding of cGxP principles and familiarization with ISO guidelines.\nWorking knowledge of Computer Systems Validation lifecycle and documentation.\nProficient in Microsoft Word, Excel, and PowerPoint.\nMust be able to work independently with adequate supervision, multitask, and support several projects simultaneously.\nMust demonstrate strong communication, interpersonal and teamwork skills.\nA strong understanding of technical writing and presentation skills is required.\nCompensation:\nValidation Engineer III - Base Salary Range and Yearly Bonus - $70,000 to $90,000 (dependent on years of experience and fit for the position) with up to a yearly 10% (discretionary) cash bonus\nBenefits/Perks:\nMedical Insurance - Aetna Prescription Converge | Rx\n Virtual Visits - Aetna/Teladoc\n Health Savings Accounts (HSA)\n Flexible Spending Accounts (FSA)\n\nDental Insurance - Aetna\nVision Insurance - VSP\nLife and AD&D Insurance\nDisability Benefits\nSupplemental Benefits Legal Services\n ID Theft Protection\n Travel Assistance\n\nValue Added Benefits & Services Health Advocate\n Life Assistance Program (LAP)\n Student Loan Assistance Program\n\n401K\nMonthly Cell Phone Allowance\nHours:\nThis position is onsite 5 days a week from 9 AM EST to 5:30 PM EST\nWORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:\nNoise: No extraordinary noise levels.\nStanding/Lifting: Must be able to lift at least 25 lbs.\nVisual: No extraordinary requirements.\nStress: High-paced, demanding environment to meet ambitious project goals.\nTravel required as needed 20%- 30% \nSupervisory Responsibility, if any: No\nThis position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.\nKashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.","description_format":"text","description_chars":5741,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Dental insurance","Health insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-02T09:56:34Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 17 · green card filings: 2","filings_12m":17,"filings_prev_12m":10,"green_card_filings_12m":2,"median_offered_wage_usd":99605,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":13,"band":"cold","label":"Long shot","p_open":1,"p_active":0.48,"p_room":0.28,"age_days":65,"expected_fill_days":30,"reasons":["conf:15","win:tail","crowd:"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/kashiv-biosciences-validation-engineer-iii","json_url":"https://alion.io/job/kashiv-biosciences-validation-engineer-iii.json","meta":{"generated_at":"2026-10-13T11:56:35Z","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":18573,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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":3854512},"rest":"https://alion.io/mcp/rest/get_company?id=3854512"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkashiv-biosciences-validation-engineer-iii"},{"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%2Fkashiv-biosciences-validation-engineer-iii"},{"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%2Fkashiv-biosciences-validation-engineer-iii"},{"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/kashiv-biosciences-validation-engineer-iii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkashiv-biosciences-validation-engineer-iii"}]}