{"id":2490243,"url":"https://alion.io/job/mentortg-validation-engineer-mentor-technical-group","title":"Validation Engineer - Mentor Technical Group","company":{"id":4419245,"name":"Mentor Technical Group","domain":"mentortg.com","url":"https://alion.io/company/mentortg","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Juncos, Puerto Rico"],"countries":["PR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":41000,"max_usd":99000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":4533},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-10-14T01:54:03Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-14T07:57:47Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.\nResponsibilities:\nCollaborate with Engineering, Quality, Packaging, Automation, and IT teams to develop and maintain serialization and aggregation validation procedures and documentation.\nDevelop, review, execute, and approve IQ, OQ, PQ, FAT, and SAT protocols and reports for serialization and track-and-trace systems.\nExecute commissioning, qualification, and validation activities for serialization equipment, aggregation systems, and packaging line integrations.\nSupport the implementation, configuration, and lifecycle management of serialization hardware and software platforms.\nCoordinate with external consultants, system integrators, equipment vendors, and internal stakeholders to ensure timely document generation and protocol execution.\nManage Change Controls, Deviations, CAPAs, and risk assessments related to serialization systems and packaging operations.\nEnsure compliance with cGMP, FDA regulations, 21 CFR Part 11, Data Integrity, DSCSA, EU FMD, and other applicable serialization requirements.\nSupport maintenance and calibration activities to improve system reliability, compliance, and operational efficiency.\nProvide expertise in troubleshooting serialization equipment, aggregation systems, vision systems, printers, scanners, and software applications.\nParticipate in root cause investigations and drive implementation of corrective and preventive actions.\nSupport audit readiness activities and regulatory inspections.\nFacilitate the transfer of technical knowledge and provide training on serialization systems, validation methodologies, and regulatory requirements.\nQualifications / Requirements / Knowledge / Education / Skills:\nBachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Computer Systems, or a related scientific field.\nMinimum of two (2) years of experience in GMP-regulated pharmaceutical manufacturing, commissioning, qualification, validation, or serialization projects.\nExperience with serialization and aggregation systems within pharmaceutical packaging operations is preferred.\nStrong knowledge of cGMP regulations, FDA requirements, 21 CFR Part 11, Data Integrity, DSCSA, EU FMD, and industry best practices.\nExperience developing, executing, and reviewing IQ/OQ/PQ validation documentation.\nFamiliarity with serialization and track-and-trace platforms such as SAP ATTP, TraceLink, Systech, Optel, Antares Vision, or equivalent technologies.\nKnowledge of Change Control, CAPA, Deviation Management, and Risk Assessment processes.\nStrong understanding of computerized systems validation (CSV) and GAMP 5 principles is highly desirable.\nProficiency in English; bilingual English and Spanish is preferred.\nExcellent analytical, problem-solving, technical writing, and communication skills.\nAbility to work collaboratively in a cross-functional team environment.\nProficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Project).\nMentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.\n Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.","description_format":"text","description_chars":4192,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Spanish","level":"Proficiency (C2)","optional":true},{"language":"English","level":"Proficiency (C2)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-14T01:54:03Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":23,"reasons":["conf:4","win:early","comp:junior,brand"],"computed_at":"2026-10-14T06:34:16Z"},"pay":null,"html_url":"https://alion.io/job/mentortg-validation-engineer-mentor-technical-group","json_url":"https://alion.io/job/mentortg-validation-engineer-mentor-technical-group.json","meta":{"generated_at":"2026-10-14T15:31:49Z","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":19588,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"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":4419245},"rest":"https://alion.io/mcp/rest/get_company?id=4419245"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmentortg-validation-engineer-mentor-technical-group"},{"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%2Fmentortg-validation-engineer-mentor-technical-group"},{"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%2Fmentortg-validation-engineer-mentor-technical-group"},{"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/mentortg-validation-engineer-mentor-technical-group\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmentortg-validation-engineer-mentor-technical-group"}]}