{"id":764834,"url":"https://alion.io/job/verista-6243-downstream-principal-engineer-lead-validation-engineer","title":"6243 - Downstream Principal Engineer / Lead Validation Engineer","company":{"id":685429,"name":"Verista","domain":"verista.com","url":"https://alion.io/company/verista-2","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":76,"open_postings":20,"ghost_share":0,"stale_share":0.95,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"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":107800,"max":168011,"currency":"USD","period":"year","gross":null,"usd_annual":168011},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Chromatography","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-03-06T15:18:53Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-06T08:33:56Z","board_verified":true,"closed_at":null,"days_open":244,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":244},"description":"Description\nVerista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.\nOur ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.\nCompany Culture Guidelines & Values:\nWe empower and support our colleagues\nWe commit to client success at every turn\nWe have the courage to do the right thing\nWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.\nWe constantly acquire new skills and learn from our experiences to enhance our collective expertise\nWe are seeking a Downstream Principal Engineer is responsible for overseeing the commissioning and qualification of downstream systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.\nDownstream Principal Engineer Responsibilities:\nDownstream System Leadership\nServe as the commissioning and qualification lead for Downstream systems (responsibilities described below).\nSpecific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems.\nC&Q Lead Responsibilities\nCommissioning and Qualification Documentation\nGain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.\nDevelop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).\nEngage with design engineers and SMEs to clarify system intent and operational requirements.\nEnsure alignment with quality, automation, and engineering teams on critical parameters and documentation.\nCreate Commissioning Test Plans that translate design intent into testable steps.\nCoordinate with the Automation Team to incorporate all automation functional testing.\nCollaborate with SMEs to ensure system requirements are accurately reflected in test plans.\nDevelop Installation, Operational, and Qualification (IOQ) protocols.\nPrepare and submit summary reports documenting commissioning and qualification activities.\nSystem Ownership and Execution\nTake custody of the system post-construction and maintain ownership through C&Q completion.\nPerform Lockout/Tagout (LOTO) for system safety.\nConduct pre-startup safety checks and risk assessments.\nPrepare daily pre-task plans and verify team readiness for safe execution.\nAttend daily commissioning meetings to coordinate activities.\nExecute commissioning and IOQ protocols.\nResolve issues arising during execution.\nParticipate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.\nRequirements:\nBachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline\n10+ years of role specific experience\nExperience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments\nHands-on experience with downstream bioprocess equipment and purification systems\nStrong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)\nAbility to work independently while collaborating with cross-functional teams\nStrong documentation, organizational, and communication skills\nExperience with digital validation systems such as Kneat\nExperience supporting FAT/SAT, commissioning, and equipment startup\nFamiliarity with risk-based validation approaches\nExperience in biologics manufacturing or monoclonal antibody production environments\nOnsite job requirement in Holly Springs, NC\n For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.\n*Verista is an equal opportunity employer.\nNational (US) Range\n$107,800—$168,011 USD\nBenefits\nWhy Choose Verista?\nHigh growth potential and fast-paced organization with a people-focused culture\nCompetitive pay plus performance-based incentive programs\nCompany-paid Life, Short-Term, and Long-Term Disability Insurance.\nMedical, Dental & Vision insurances\nFSA, DCARE, Commuter Benefits\nSupplemental Life, Hospital, Critical Illness and Legal Insurance\nHealth Savings Account\n401(k) Retirement Plan (Employer Matching benefit)\nPaid Time Off (Rollover Option) and Holidays\nAs Needed Sick Time\nTuition Reimbursement\nTeam Social Activities (We have fun!)\nEmployee Recognition\nEmployee Referral Program\nPaid Parental Leave and Bereavement\nVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. \nFor more information about our company, please visit us at Verista.com","description_format":"text","description_chars":5478,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Engineering Services","Healthcare & Life Sciences Consulting"],"lifecycle":[{"event":"open","at":"2026-09-11T19:41:25Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1 · green card filings: 3","filings_12m":1,"filings_prev_12m":6,"green_card_filings_12m":3,"median_offered_wage_usd":102500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.183,"p_room":0.28,"age_days":244,"expected_fill_days":34,"reasons":["conf:1","stale_co","win:tail","crowd:"],"computed_at":"2026-11-06T05:58:05Z"},"pay":{"stated_usd_annual":168011,"is_top_pay":true},"html_url":"https://alion.io/job/verista-6243-downstream-principal-engineer-lead-validation-engineer","json_url":"https://alion.io/job/verista-6243-downstream-principal-engineer-lead-validation-engineer.json","meta":{"generated_at":"2026-11-06T09:29:31Z","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":17154,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":685429},"rest":"https://alion.io/mcp/rest/get_company?id=685429"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fverista-6243-downstream-principal-engineer-lead-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%2Fverista-6243-downstream-principal-engineer-lead-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%2Fverista-6243-downstream-principal-engineer-lead-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/verista-6243-downstream-principal-engineer-lead-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fverista-6243-downstream-principal-engineer-lead-validation-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":764834}},{"tool":"search_jobs","arguments":{"company":"verista.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":764834},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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