{"id":3226790,"url":"https://alion.io/job/genentech-principal-validation-engineer-cvrm","title":"Principal Validation Engineer, CVRM","company":{"id":1757810,"name":"Genentech","domain":"gene.com","url":"https://alion.io/company/gene-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Holly Springs, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":95000,"max":176000,"currency":"USD","period":"year","gross":null,"usd_annual":176000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-23T00:00:00Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-25T08:03:20Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Welcome to Holly Springs, North Carolina- home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.\nThe facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.\nAre you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation.\nJoin us in Holly Springs, where you won't just build a plant-you will build the future of medicine.\nThe Opportunity\nDevelops, implements and maintains validation status of the application equipment and manufacturing processes. Estimates qualifications needs, material needs and verifies pre requisite completions. Works independently within guidelines and policies, and receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance.\nThe Principal Validation Engineer will be accountable for performing activities such as Equipment Commissioning and Qualification, Cycle Development (CD), Performance Qualification (PQ) and Re-Qualification (RPQ) / Cleaning Validation (CV) and Process Validation (PV) in support of technology transfer and new technology introduction to the Hollysprings, North Carolina site.\nWhat You'll Do\nDevelop and manage the detailed project plans, validation plansand timelines for the execution of validation activities. \nAuthor, execute and summarize various qualifications for sterilization systems and equipment, cleaning system, filling equipment and supporting equipment (Autoclaves, Parts washer etc.).\nPrepare change control documentation, including protocols, summary reports, etc., for all activities. \nSupport project manager ensuring new systems are implemented within predetermined timelines and financial forecasts. \nPresent and provide rationale for completed work during periodic audits and Health Authority inspections. \nProcure and manage contractor support for outsourced validation and risk management assignments. \nSupport the change management system for new processes, equipment, utilities and facilities. \nPrepare, review and approve relevant sections of regulatory submissions. \nServe as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA. \nLead and facilitate Risk Assessment sessions. \nProvide input into investigations and change control with potential impact to the site risk profile. \nFoster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. \nMentor more junior validation engineers and train individuals on practices and procedures.\nClosely collaborates with site and network organizations seamlessly \nConstantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity\nAble to provide the leadership necessary to maintain a high performance culture\nWho You Are\nBS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8+ years experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required. \nExperience in the pharma/biotech industry is required\nKnowledge of cGMPs or equivalent regulations \nWorking knowledge of facilities, utilities, formulation, filling, and packaging, equipment qualification in a regulated environment is required. Hands on qualification experience with the majority of sterile filling equipment and support systems. \nDemonstrated project management skills\nAbility to work with internal teams, partners, suppliers and customers \nOperational excellence and industrial engineering skills are a plus\nProfessional level written and oral communication skills required\nRelocation benefits are available for this position.\nThe expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $95,000 - $176,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.\nLink to Benefits\nGenentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.\nIf you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.","description_format":"text","description_chars":5969,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Biotechnology","Health Care","Care Coordination & Population Health"],"lifecycle":[{"event":"open","at":"2026-10-25T06:04:32Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":23,"reasons":["conf:1","win:early"],"computed_at":"2026-10-25T09:38:26Z"},"pay":{"stated_usd_annual":176000,"is_top_pay":true},"html_url":"https://alion.io/job/genentech-principal-validation-engineer-cvrm","json_url":"https://alion.io/job/genentech-principal-validation-engineer-cvrm.json","meta":{"generated_at":"2026-10-25T09:38:26Z","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":13810,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":1757810},"rest":"https://alion.io/mcp/rest/get_company?id=1757810"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenentech-principal-validation-engineer-cvrm"},{"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%2Fgenentech-principal-validation-engineer-cvrm"},{"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%2Fgenentech-principal-validation-engineer-cvrm"},{"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/genentech-principal-validation-engineer-cvrm\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenentech-principal-validation-engineer-cvrm"}]}