{"id":1532880,"url":"https://alion.io/job/beone-medicines-engineer-ii-automation-validation","title":"Engineer II, Automation Validation","company":{"id":99686,"name":"BeOne Medicines","domain":"beonemedicines.com","url":"https://alion.io/company/beonemedicines","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":77,"open_postings":22,"ghost_share":0,"stale_share":0.909,"repost_share":0,"time_to_fill_p50_days":39,"computed_at":"2026-10-15T05:46:00Z"}},"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":["Hopewell, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":99700,"max":134700,"currency":"USD","period":"year","gross":null,"usd_annual":134700},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Microsoft Office","optional":true},{"name":"Outlook","optional":true}],"status":"live","first_seen_at":"2026-09-30T17:05:17Z","employer_posted_date":"2026-09-30","last_verified_at":"2026-10-14T23:54:00Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.\nGeneral Description:\nEngages in the day-to-day activities of the Automation Validation and CSV function, ensuring the successful management of related activities and large projects. Supports Automation Validation and CSV objectives, whilst adhering to regulatory compliance and achieving commercial success. This is a site-based position supporting the facility and will require gowning into the manufacturing suites.\nEnsures the Automation Validation and CSV function supports operational needs and ensures regulatory compliance requirements are met. Works to support Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed to support the business. Works to support both internal GMP audits and Health Authority audits. Supports Automation Validation and CSV related tasks as assigned by Management.\nResponsibilities\nDevelop and approve cGMP documents including, but not limited to: Automation Qualification, Commissioning, Master Validation Plans, SOP’s, Comparability reports, Periodic Reviews, and Requalification.\nLead validation activities for automated manufacturing systems, equipment, control systems, and computerized systems.\nDevelop and maintain automated test scripts and frameworks where appropriate.\nValidate PLC, HMI, SCADA, DCS, EMS, vision systems, data acquisition systems, and related automation platforms.\nEvaluate automation and computerized systems for compliance with applicable GxP, data integrity, and electronic records requirements.\nParticipate in system design reviews, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and production implementation.\nPerform risk-based assessments to identify critical process parameters, system functions, and validation requirements.\nEnsuring that the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed.\nLeading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements.\nReview of equipment specification/design/procurement/installation and validation.\nProject planning and execution including scheduling, task management, milestone planning and reporting.\nGeneration, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures.\nEmployee will be required to work closely with both manufacturing, quality, and engineer associates.\nEnsuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.\nPosition flows based on project needs up to and including quality approvals. \nUndertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.\nRequired Skills/Experience\nBS or higher in engineering and/or Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).\nStrong knowledge of cGMP’s.\nKnowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.\nBiotech and/or Sterile manufacturing and aseptic processing knowledge required.\nMinimum of 4 years’ experience in validation (with Bachelors degree) or 3 years (with a Masters degree), biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.\nKnowledge of cGMP’s and Data Integrity principles.\nDemonstrable track record and skills/experience gained within a similar position(s), at a similar level. Good personal leadership.\nGood communicator (written and verbal) at all levels.\nCustomer focused. Strong analytical and problem-solving ability.\nHands-on approach, with a ‘can do’ attitude. Able to work under minimal or appropriate supervision level.\nAbility to prioritize, demonstrating good time management skills.\nExcellent attention to detail, with the ability to work accurately in a busy and demanding environment.\nSelf-motivated, with the ability to work proactively using own initiative.\nHighly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.\nPreferred Skills/Experience\nKnowledgeable in Computerized System Validation (CSV) and/or Automation Validation.\nHighly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.\nPhysical Requirements:\nAbility to work in an office environment, construction site, and laboratory or manufacturing areas.\nMay require up to 5% travel, including visits to partner or manufacturing sites.\nMust be able to sit, stand, and use standard office equipment for extended periods.\nGlobal Competencies\nWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.\nFosters Teamwork\nProvides and Solicits Honest and Actionable Feedback\nSelf-Awareness\nActs Inclusively\nDemonstrates Initiative\nEntrepreneurial Mindset\nContinuous Learning\nEmbraces Change\nResults-Oriented\nAnalytical Thinking/Data Analysis\nFinancial Excellence\nCommunicates with Clarity\nSalary Range: $99,700.00 - $134,700.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.\nWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .","description_format":"text","description_chars":7984,"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":[]},"benefits":["Continuous learning","Equity","Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-30T17:05:17Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 30","filings_12m":30,"filings_prev_12m":14,"green_card_filings_12m":0,"median_offered_wage_usd":187500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":53,"band":"ok","label":"Likely open","p_open":1,"p_active":0.587,"p_room":0.9,"age_days":14,"expected_fill_days":39,"reasons":["conf:5","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-15T05:46:00Z"},"pay":{"stated_usd_annual":134700,"is_top_pay":true},"html_url":"https://alion.io/job/beone-medicines-engineer-ii-automation-validation","json_url":"https://alion.io/job/beone-medicines-engineer-ii-automation-validation.json","meta":{"generated_at":"2026-10-15T18:22:49Z","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":27899,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"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":99686},"rest":"https://alion.io/mcp/rest/get_company?id=99686"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbeone-medicines-engineer-ii-automation-validation"},{"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%2Fbeone-medicines-engineer-ii-automation-validation"},{"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%2Fbeone-medicines-engineer-ii-automation-validation"},{"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/beone-medicines-engineer-ii-automation-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbeone-medicines-engineer-ii-automation-validation"}]}