{"id":1710553,"url":"https://alion.io/job/leiters-validation-engineer","title":"Validation Engineer","company":{"id":3799549,"name":"Leiters","domain":"leiters.com","url":"https://alion.io/company/leiters","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","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":"inferred","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":97308,"max":121608,"currency":"USD","period":"year","gross":null,"usd_annual":121608},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Outlook","optional":true}],"status":"live","first_seen_at":"2026-09-15T20:05:00Z","employer_posted_date":"2026-09-15","last_verified_at":"2026-10-09T23:06:42Z","board_verified":true,"closed_at":null,"days_open":24,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":24},"description":"The Validation Engineer reports directly to the Manager of Validation. The role is responsible for acting as a Subject Matter Expert (SME) for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, electronic system validation, shipping validation, and program maintenance. This role ensures all systems operate within regulations to ensure the production of quality products.\nWhy Join Leiters Health? \nAre you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team!\nAt Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.\nInnovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.\nMeaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.\nProfessional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.\nCutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.\nCollaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.\nWho We're Looking For: \nWe're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today\nEssential Functions:\nThis description is intended to be illustrative of the major duties performed by the employee assigned to this position.\nWorks on projects/matters in a supporting capacity. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group.\nWork alongside commissioning agents to complete initial facility qualification and bring systems and processes online.\nUtilizes Project Management skills to plan and coordinate efforts with a cross-functional team.\nCompletes tasks in a timely fashion and communicate task status to management and/or project team.\nAdheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, and CAPAs.\nCoordination of Validation activities with stakeholders.\nSupport in writing and executing protocols for Validation work.\nIdentifies and resolves non-conformances/discrepancies encountered during IQ/OQ/PQ execution and work with cross function team to implement mitigation solutions.\nGenerate reports and summarize results, including confirming the document is suitable to be shared with regulatory agencies.\nSupports creation or revision of Validation templates for protocols and reports.\nSupports creation and review of Engineering Documentation (URS, FS, SAT, FAT).\nAct as a subject matter expert for all site qualification and validation activities.\nSupports project work as a specialist on complex technical matters.\nMentoring of less experienced team members.\nOther duties as assigned. \nSupervisory Responsibilities:\nN/A \nExperience & Necessary Competencies\nBachelor's degree in a STEM field required; i.e. engineering, chemistry, or relevant industry experience. \n4+ years of validation experience, preferably in a highly regulated environment. \nExperience in project management preferred \nDemonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.)\nStrong curiosity and willingness to learn, along with the tenacity and drive to see projects through.\nWillingness to support tasks outside normal job description, as needed. Can-do attitude! \nAbility to create technical and professional documents.\nStrong attention to detail and accuracy. \nAbility to multi-task, with strong organization and time-management. \nAbility to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis. \nUnderstanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!\nProficient written, verbal and oral English communication skills are required.\nProficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. \nPhysical Requirements:\nAbility to stand or sit for extended periods of time.\nAbility to lift, push and pull up to 50 pounds periodically. \nAbility to maintain a gowning qualification and adhere to aseptic practices.\nBenefits:\nSmart healthcare coverage options that rewards wellness (and puts money back in your pocket!)\nFlexible Spending & Health Savings Accounts (FSA & HSA) available\nDental & Vision insurance \nEmployer Paid Life Insurance & Employee Assistance Program\nShort Term & Long-Term Disability Insurance\nUp to 4% 401K Matching (100% vested on day one!)\nGenerous Paid Time Off Options - vacation, sick, paid leave and holidays!\n$5,250 Annual Tuition Reimbursement after 6 months\n$1,000 Referral Bonus Program with no limit\nEligible for annual bonus program\nTimeline: We will be accepting applications on an ongoing basis until position is filled.\nWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. \n*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.","description_format":"text","description_chars":6587,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":["401k plan","Growth opportunities","Life insurance","Professional development","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Hospitals & Health Systems","Process Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-02T17:11:53Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":92500,"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)"],"filings_for_role_12m":0}],"liveness":{"score":59,"band":"ok","label":"Likely open","p_open":1,"p_active":0.789,"p_room":0.75,"age_days":23,"expected_fill_days":30,"reasons":["conf:0","urgency","win:late"],"computed_at":"2026-10-09T06:01:00Z"},"pay":{"stated_usd_annual":121608,"is_top_pay":true},"html_url":"https://alion.io/job/leiters-validation-engineer","json_url":"https://alion.io/job/leiters-validation-engineer.json","meta":{"generated_at":"2026-10-10T00:32:49Z","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","counted_by":"address","units_charged":1,"used_today":859,"day_limit":5000,"remaining_today":4141,"minute_limit":60,"resets_at":"2026-10-11T00:00:00Z"}},"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":3799549},"rest":"https://alion.io/mcp/rest/get_company?id=3799549"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fleiters-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%2Fleiters-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%2Fleiters-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/leiters-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fleiters-validation-engineer"}]}