{"id":3001094,"url":"https://alion.io/job/shl-medical-process-and-validation-engineer","title":"Process and Validation Engineer","company":{"id":1964724,"name":"SHL Medical","domain":"shl-medical.com","url":"https://alion.io/company/shl-medical","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Zug, Switzerland"],"countries":["CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":63000,"max_usd":140000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":5256},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design of Experiments","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-21T12:13:36Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-24T04:50:46Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"About SHL Medical\nSHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.\nJob Overview\nThis role is embedded in the Operations Engineering Team within our Global Operations Engineering Department at our new state-of-the-art device manufacturing facility and HQ in Zug, Switzerland. This role serves at the intersection between process engineering and validation with the candidate expected to understand and support onsite validation activities, as well as serving as a process SME, driving improvements and supporting investigations and troubleshooting.\nMain Responsibilities\nAct as a process SME, leading and supporting process introduction, development, troubleshooting, and improvement initiatives at the site\nLead and support acceptance and CQV activities (commissioning, qualification, and validation) for production equipment and processes, including developing/authoring compliant validation plans and protocols, as well as supporting the associated change control processes\nCollaborate internally and across departments to drive improvements to SHL’s production equipment and associated processes\nWork with the broader validation team, including global colleagues, to drive efficiency, simplicity, and robustness in validation process updates\nProvide input and make updates to validation-related SOPs, work instructions, and guidelines to improve the overall validation lifecycle\nWork with fellow engineers to drive and support root cause analysis, NCMR investigation, and CAPA planning\nProvide support for internal and external audits and investigations both through validation documentation ownership, as well as technical SME input\nRemaining up-to-date and ensuring compliance with current industry trends as well as Quality Systems, ISO13485, cGMP and other relevant regulatory protocols\nPerforms other related duties as assigned.\nMinimum Requirements\nMinium of 3 years of relevant experience as a Process Engineer and/or Validation Engineer, preferably in in the medical device industry\nExperience as a process SME in high-volume production settings (e.g. injection molding, packaging/printing, metal forming) \nDemonstrated knowledge of regulations and standards that apply to the medical device industry (cGMP, ISO13485, CFR 820, etc.)\nUnderstanding of the application of quality systems to the medical device industry\nStatistical analysis knowledge, including an understanding of how to execute and interpret Design of Experiments (DOE)\nKnowledge of common problem-solving and Root Cause Analysis (RCA) methodologies. Six Sigma certification is a plus\nFluency in English & German, both written and spoken, is required\nPreferred Qualifications\nAbility to perform multiple tasks and prioritize workload.\nEffective analytical, technical, and problem-solving skills.\nExcellent intercultural and interdisciplinary communication skills\nAbility to work independent with strong attention to detail and focus on efficiency, effectiveness and cost\nPassionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the jobdone\nFluency in Mandarin, both written and spoken, is preferred. \nWe Offer\nChallenging assignments in a fast-growing and innovative industry.\nA multicultural team and modern working environment with state-of-the-art facilities and technologies.\nA place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.\nVarious opportunities for personal and professional development within a global organization.\nFlexible hours and hybrid working policy. \nInterested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.\nFor more information on SHL Medical, please visit: shl-medical.com/careers\nPlease note: We do not accept applications from recruitment agencies for this position.","description_format":"text","description_chars":4625,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"German","level":"All levels","optional":false},{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Hybrid work","Professional development"],"hiring_locations":[{"name":"Switzerland","iso":"CH","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-10-21T12:13:36Z"}],"visa":[],"liveness":{"score":89,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.89,"p_room":1,"age_days":1,"expected_fill_days":7,"reasons":["conf:0","velocity","win:early"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/shl-medical-process-and-validation-engineer","json_url":"https://alion.io/job/shl-medical-process-and-validation-engineer.json","meta":{"generated_at":"2026-10-24T05:03:10Z","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":7127,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":1964724},"rest":"https://alion.io/mcp/rest/get_company?id=1964724"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fshl-medical-process-and-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%2Fshl-medical-process-and-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%2Fshl-medical-process-and-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/shl-medical-process-and-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fshl-medical-process-and-validation-engineer"}]}