{"id":1755234,"url":"https://alion.io/job/sire-life-sciences-quality-engineer-csv","title":"Quality Engineer CSV","company":{"id":2218112,"name":"SIRE Life Sciences","domain":"sire-search.com","url":"https://alion.io/company/sire-search","size_band":"51-200","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":{"grade":"B","score":75,"open_postings":22,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-06T05:45:30Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hoofddorp, Netherlands"],"countries":["NL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":63000,"max_usd":107000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":17},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-06T00:00:00Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-03T19:50:44Z","board_verified":false,"closed_at":null,"days_open":61,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":61},"description":"About the CompanyOur client is a globally recognized leader in the cell therapy and biopharmaceutical industry, dedicated to developing innovative treatments for patients with serious diseases. Operating in a highly regulated GMP environment, the organization combines cutting-edge technology with a strong quality culture, offering professionals the opportunity to work on advanced manufacturing systems that directly contribute to life-changing therapies. The company values collaboration, continuous improvement, and operational excellence.\nAbout the Role\nWe are looking for an experienced Senior Quality Engineer I - Computer System Validation (CSV) to join a quality team supporting Manufacturing Execution System (MES) projects. In this role, you will provide quality oversight for computer system validation activities, ensuring that manufacturing systems remain compliant with GMP and regulatory requirements. You will collaborate closely with engineering, validation, and manufacturing teams while helping drive quality improvements across the site.\nResponsibilities\nProvide quality oversight for Computer System Validation (CSV) activities related to MES projects.\nReview and approve validation documentation, including new system qualifications, system changes, and periodic revalidation.\nEnsure computerized systems comply with GMP and regulatory expectations.\nSupport Continuous Commissioning, Qualification & Validation (CQV) activities from a quality perspective.\nParticipate in Quality Risk Management activities and assess the impact of system changes.\nHelp develop and monitor quality KPIs to identify improvement opportunities.\nInvestigate quality deviations and contribute to effective corrective and preventive actions.\nWork closely with cross-functional teams to maintain high standards of quality and compliance.\nContribute to process improvements and support inspection and audit readiness.\nQualifications\nBachelor's degree (BSc) in Engineering, Life Sciences, Computer Science, or a related technical field.\nRequired Skills\nProven experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.\nHands-on experience with Werum PAS-X is mandatory.\nStrong understanding of GMP, computerized system validation, and regulatory compliance.\nExperience reviewing and approving validation documentation.\nExcellent communication and technical writing skills.\nAbility to work independently while collaborating effectively with multidisciplinary teams.\nPreferred Skills\nExperience with Quality Risk Management tools such as FMEA or HACCP is an advantage.\nKnowledge of Lean Six Sigma or DMAIC methodologies is considered a plus.\n58647","description_format":"text","description_chars":2714,"description_truncated":false,"requirements":{"experience_years_min":null,"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":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-03T10:30:45Z"}],"visa":[],"liveness":{"score":8,"band":"cold","label":"Long shot","p_open":0.9,"p_active":0.232,"p_room":0.36,"age_days":61,"expected_fill_days":40,"reasons":["conf:57","agency","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-06T05:45:30Z"},"pay":null,"html_url":"https://alion.io/job/sire-life-sciences-quality-engineer-csv","json_url":"https://alion.io/job/sire-life-sciences-quality-engineer-csv.json","meta":{"generated_at":"2026-10-06T20:59:39Z","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","counted_by":"address","units_charged":1,"used_today":68,"day_limit":5000,"remaining_today":4932,"minute_limit":60,"resets_at":"2026-10-07T00:00:00Z"}},"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":2218112},"rest":"https://alion.io/mcp/rest/get_company?id=2218112"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsire-life-sciences-quality-engineer-csv"},{"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%2Fsire-life-sciences-quality-engineer-csv"},{"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%2Fsire-life-sciences-quality-engineer-csv"},{"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/sire-life-sciences-quality-engineer-csv\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsire-life-sciences-quality-engineer-csv"}]}