{"id":764837,"url":"https://alion.io/job/verista-6245-solution-prep-principal-engineer-lead-validation-engineer","title":"6245 - Solution Prep 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":["Apex, 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":"GMP","optional":false},{"name":"Cell Culture","optional":true}],"status":"live","first_seen_at":"2026-03-06T15:30:21Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-06T12:50:25Z","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 Solution Prep Principal Engineer with hands-on experience supporting solution preparation systems within biopharmaceutical manufacturing environments. This role will focus on solution preparation, buffer preparation, and media preparation unit operations, supporting commissioning, qualification, and validation activities to ensure systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.\nThe ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting equipment startup and commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.\nThis position requires an individual who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.\nSolution Preparation Principal Engineer Responsibilities:\nCommissioning, Qualification & Validation\nSupport commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.\n\nAuthor, review, and execute CQV lifecycle documentation including:\nCommissioning test protocols\n\nInstallation Qualification (IQ)\n\nOperational Qualification (OQ)\n\nPerformance Qualification (PQ)\n\nValidation summary reports\n\nEnsure validation documentation complies with cGMP regulations and internal quality procedures.\n\nParticipate in system impact assessments, risk assessments, and validation planning activities.\n\nSolution Preparation Process Support\nProvide technical support for solution preparation unit operations, including systems such as:\nBuffer preparation systems\n\nMedia preparation systems\n\nSolution preparation tanks and mixing systems\n\nSingle-use mixing systems\n\nTransfer and hold systems\n\nSupport equipment startup and operational readiness for solution preparation processes.\n\nAssist with troubleshooting and process verification during commissioning and qualification activities.\n\nVendor & Equipment Startup\nSupport Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.\n\nCoordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.\n\nParticipate in equipment startup, commissioning, and operational testing activities.\n\nCross-Functional Coordination\nCollaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.\n\nAssist with deviation investigations, change control processes, and documentation updates.\n\nEnsure CQV activities align with project schedules and operational readiness milestones.\n\nDigital Validation Systems\nUtilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.\n\nMaintain data integrity, traceability, and compliance within digital validation systems.\n\nRequirements:\nBachelor’s degree in Engineering, Biotechnology, Life Sciences, or related technical field\n\n10+ years of role specific experience\nExperience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments\n\nHands-on experience with solution preparation, buffer prep, or media prep systems\n\nStrong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)\n\nAbility to work independently while coordinating with cross-functional teams\n\nStrong technical documentation and communication skills\n\nExperience using digital validation platforms such as Kneat\n\nExperience supporting FAT/SAT, commissioning, and equipment startup\n\nFamiliarity with single-use systems and biologics manufacturing processes\n\nExperience working within biologics or cell culture manufacturing facilities\n\nOnsite job requirement in Apex, 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":6488,"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-6245-solution-prep-principal-engineer-lead-validation-engineer","json_url":"https://alion.io/job/verista-6245-solution-prep-principal-engineer-lead-validation-engineer.json","meta":{"generated_at":"2026-11-06T13:39:10Z","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":25083,"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-6245-solution-prep-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-6245-solution-prep-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-6245-solution-prep-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-6245-solution-prep-principal-engineer-lead-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fverista-6245-solution-prep-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":764837}},{"tool":"search_jobs","arguments":{"company":"verista.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":764837},"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. Docs: https://alion.io/developers"}}