{"id":4050909,"url":"https://alion.io/job/tolmar-validation-engineer-i","title":"Validation Engineer I","company":{"id":3246838,"name":"Tolmar","domain":"tolmar.com","url":"https://alion.io/company/tolmar","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":47,"computed_at":"2026-11-14T05:58:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Windsor, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":73000,"max":83000,"currency":"USD","period":"year","gross":null,"usd_annual":83000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Sterilization Validation","optional":false}],"status":"live","first_seen_at":"2026-11-10T23:51:55Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-14T05:04:30Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Purpose and Scope\nThe Validation Engineer I is responsible for supporting the planning, execution, and documentation of validation activities in a sterile injectable manufacturing environment. Responsibilities include equipment, facilities, utilities, cleaning and process validation in compliance with cGMP, FDA, EU, and other regulatory requirements.\nEssential Duties & Responsibilities\nAssist in the development and execution of validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities (e.g., CTUs, WFI, HVAC), and processes.\nSupport cleaning and sterilization validation activities, including autoclaves, SIP systems, and aseptic processes.\nParticipate in risk assessments (e.g., FMEA) and support change control evaluations.\nCollect and analyze validation data, prepare summary reports, and ensure documentation is accurate and audit-ready.\nCollaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Quality Control.\nMaintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.\nSupport investigations and CAPAs related to validation deviations or failures.\nStay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.\nParticipate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.\nPerform other related duties as assigned.\nCore Values\nThis position is expected to operate within the framework of Tolmar’s Core Values:\nCenter on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.\nAre Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.\nAct Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.\nConstantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.\nAre Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.\nKnowledge, Skills & Abilities\nProficient in Microsoft Office Suite.\nKnowledge of GMP regulations and validation guidelines. \nStrong technical writing and documentation skills.\nExcellent oral and written communication skills.\nEffective organizational and project management skills.\nEffective troubleshooting and problem-solving skills.\nAbility to maintain gowning requirements for controlled areas.\nAbility to manage multiple projects simultaneously.\nAbility to work both independently and as part of a team.\nAbility to develop and implement creative solutions to problems.\nEducation & Experience\nBachelor’s degree in Engineering, Life Sciences, or a related technical field.\nSome experience in validation, preferably in a sterile pharmaceutical or biotech environment.\nUnderstanding of GMP, FDA and EU regulatory requirements a plus.\nExperience qualifying CTUs and using Ellab temperature mapping systems a plus.\nWorking Conditions\nWorking conditions include general office environment , laboratory and manufacturing settings (clean rooms where gowning is required)\nBusiness demands may require working extended hours.\nCompensation and Benefits\nPay: $73,000 - $83,000 annually\nBenefits summary: https://www.tolmar.com/careers/employee-benefits \nTolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. 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