{"id":2362853,"url":"https://alion.io/job/us-worldmeds-computer-system-quality-validation-engineer","title":"Computer System Quality Validation Engineer","company":{"id":2540669,"name":"US WorldMeds","domain":"usworldmeds.com","url":"https://alion.io/company/usworldmeds","size_band":null,"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":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Philadelphia, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":87000,"max_usd":165000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5037},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-01T22:29:00Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-13T13:26:12Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"SUMMARY: US WorldMeds is seeking a Computer System Validation Engineer to play a pivotal part in ensuring the compliance and efficiency of computerized systems involved in several stages of the Validation-cycle, from the upstream capturing the patient journey to the integration process as well as managing Quality Compliance of IT Systems relevant for GxP regulations. Proven end-to-end CSV experience, including planning, execution, documentation, and remediation. As a member of the Quality organization, an additional requirement is to provide Quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and USWM’s validation practices and procedures.Familiarity with regulatory requirements around audit trails and access control is a plus.\nDUTIES AND RESPONSIBILITIES:\nThe following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.\nResponsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of systems and applications to support GxP operations.\nCollaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing.\nLead validation teams to a better understanding of validation best practices and applying quality principles.\nReviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.\nCollaborate with cross-functional teams on the integration of data systems and implementation of audit trails, access controls, and data integrity strategies.\nIdentifies and resolves issues interfering with execution of deliverables.\nEnforces Good Documentation Practices and ensures that SDLC deliverables are properly archived and available for internal and external regulatory inspection.\nCollab with Supplier Quality Management to ensure vendor compliance to regulations and standards before introducing instruments or applications into the lab and production environment.\nAttend meetings as quality representative and capture meeting minutes, escalating items as appropriate.\nLiaise with key personnel within project teams to ensureproject remains on target for key milestones.\nResponsible for QA review and approval of all validation records and documentation (i.e. computer system validation and equipment lifecycle documentation including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports).\nReview and approve protocol discrepancies related to manufacturing process equipment, utilities, computer systems, validation, and laboratory instruments.\nEnsure GMP compliance in all areas of validation/qualification and that systems are fully validated/qualified and all documentation completed before they are released for GMP use.\nResponsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation.\nMaintain inspection readiness and actively support regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors.\nParticipate in routine plant operating meetings (CAPA, Deviation, Change Control) and serve as Quality Engineering SME.\nParticipate in efforts to identify opportunities for and to implement continuous improvement and optimization of practices related to validation.\nQUALIFICATIONS:\nRequired\nBachelor’s Degree in Science or related technical field. \nMinimum of 5 years of Quality Assurance/Validation experience working with automation and/or computerized system validations in the biotechnology or pharmaceutical industries. \nMust demonstrate understanding of cGMP’s, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations. \nPrior experience leading or managing projects beneficial\nStrong knowledge of global regulatory requirements for Clinical and Commercial GMP computerized systems validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11. \nKnowledge of Quality Risk Management principles and experience with performing risk assessments using a variety of tools, i.e. FMEA. \nMust be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks. \nMust possess strong verbal/written communication skills and ability to influence at all levels. \nExperience utilizing quality systems to support CSV/CSA activities (Document management, Training, Deviation management, Change Control management, and CAPA). \nProficient skills dealing with and understanding typical laboratory, facilities and manufacturing equipment for cell therapy manufacturing with single-use technologies, closed systems, and cold chain/cryogenic technologies. \nDeep knowledge of facility/clean room design, process, equipment, automation, and validation \nAbility to think strategically and to translate strategy into actions \nMust be able to prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment. \nAbility to provide clear direction to team members in a highly dynamic environment \nCandidate must be proficient in Microsoft Word, Excel, PowerPoint.\nDesirable\nExperience with Calibration manager databases, Electronic Lab Notebooks, Veeva, Validation Data Acquisition systems (ie Kaye, Ellab, TempTale), Building Management systems, Document Control Software, Sepax/SepaxNet, Wave Bioreactors/Unicorn Software, MODA, Pas-X, StarLIMS.\nExperience with leading the start-up, validation, and licensure of manufacturing facilities. \nStrong knowledge and direct experience with systems and applications required for aseptic manufacturing. \nExperience working with cell and gene therapies or biologics products. \nThe physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nPHYSICAL DEMANDS:\nFrequently required to stand\nFrequently required to walk. \nFrequently required to sit. \nFrequently required to talk or hear. \nOccasionally required to lift light weights (less than 25 pounds) \nSpecific vision abilities required for this job include: close vision, color vision and ability to adjust or focus\nWORK ENVIRONMENT:\nThe noise level in the work environment usually is quiet.\nAseptic Gowning is a requirement when executing validation work on the floor.","description_format":"text","description_chars":6943,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Prescription Drugs","Pharmacies"],"lifecycle":[{"event":"open","at":"2026-10-12T16:08:03Z"}],"visa":[],"liveness":{"score":71,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.793,"p_room":0.9,"age_days":11,"expected_fill_days":22,"reasons":["conf:1","win:mid"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/us-worldmeds-computer-system-quality-validation-engineer","json_url":"https://alion.io/job/us-worldmeds-computer-system-quality-validation-engineer.json","meta":{"generated_at":"2026-10-13T14:56:58Z","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":22822,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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":2540669},"rest":"https://alion.io/mcp/rest/get_company?id=2540669"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fus-worldmeds-computer-system-quality-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%2Fus-worldmeds-computer-system-quality-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%2Fus-worldmeds-computer-system-quality-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/us-worldmeds-computer-system-quality-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fus-worldmeds-computer-system-quality-validation-engineer"}]}