{"id":464998,"url":"https://alion.io/job/abcellera-seniorstaff-engineer-pharmaceutical-delivery","title":"Senior Engineer, Combination Products & Device Development","company":{"id":179322,"name":"AbCellera","domain":"abcellera.com","url":"https://alion.io/company/abcellera","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Vancouver, Canada"],"countries":["CA"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":116000,"max":145000,"currency":"CAD","period":"year","gross":null,"usd_annual":103079},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"Human Factors Engineering","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-01T16:33:17Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-26T23:19:54Z","board_verified":true,"closed_at":null,"days_open":55,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":55},"description":"Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.\nWe are looking for a Senior Engineer, Combination Products & Device Development to play a key technical role in advancing our combination product programs, including prefilled syringes and autoinjectors. In this role, you’ll execute design controls, translate user and product needs into technical requirements, and work with device suppliers and contract development and manufacturing organizations (CDMOs) to drive products toward clinical and commercial readiness. You’ll work closely with Quality, Regulatory, Formulation, and Drug Product teams, bringing together device engineering and biologics development to shape how our antibody therapies are delivered to patients.\nH ow you might spend your days \nDeveloping and maintaining Design History File documentation, translating user needs into design input and product requirements, and supporting design controls, design outputs, verification and validation, traceability, and design reviews throughout the product lifecycle\nExecuting device and combination product risk management activities, including development and maintenance of risk analyses and ensuring appropriate linkage among product requirements, risk controls, verification and validation activities, and device performance requirements\nSupporting Human Factors (HF) programs, from formative studies through summative validation, including development Instructions for Use (IFU), device labelling content, and associated HF engineering documentation\nConducting technical gap assessments and supporting technology transfer and scale-up activities to confirm that fill-finish, device assembly, and packaging operations can consistently meet applicable input requirements, Essential Drug Delivery Outputs (EDDOs) and other critical attributes\nManaging and supporting external technical partnerships with device component suppliers, CDMOs, testing laboratories, and consultants, providing technical oversight of project scope, work packages, deliverables, timelines, and development activities\nDeveloping and executing packaging, shipping, and distribution evaluation strategies for prefilled syringes and autoinjectors to assess EDDOs, container closure integrity, and product quality throughout distribution\nPartnering with Quality Assurance to develop, review, and maintain medical device and combination product QMS procedures, and supporting supplier controls, Quality Agreements, and other QMS activities\nPartnering with Regulatory Affairs to support device regulatory strategy and author device-related documentation for clinical and commercial submissions, including INDs, CTAs/IMPDs, BLAs, and MAAs, as programs advance through development\nW e’d love to hear from you if\nYou bring meaningful, hands-on experience in device engineering - from mechanical, biomedical, or chemical engineering, or another related field that's given you real depth in developing pharmaceutical delivery devices\nYou have 8+ years of direct experience in drug delivery systems and combination products (prefilled syringes, autoinjectors, or needle safety systems preferred), though strong medical device experience with exposure to parenteral drug delivery will also be considered\nYou possess a working knowledge of FDA Design Controls and quality system requirements for combination products (including FDA requirements under 21 CFR Parts 4 and 820) and relevant international standards (ISO 13485, ISO 11608, ISO11040, ISO 14971, IEC 62366)\nYou have direct experience working with external device partners and CDMOs, with the technical judgment to critically assess scope, challenge technical assumptions, review deliverables, and hold vendors accountable\nYou are familiar with Human Factors Engineering principles and the integration of user needs and usability considerations into formal design controls\nYou have experience supporting packaging, distribution, and transport simulation studies for parenteral drug-device combination products\nYou possess excellent cross-functional communication skills, strong attention to detail, and a collaborative mindset suited for a fast-paced biotech environment\nW hat we offer\nAbCellera’s hiring range for this role is CAD $116,000 - $145,000 annually commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, an annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.\nYou will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship are a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.\nAbout AbCellera\nCreating medicines is the most important work we can do. \nWe are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline.\nToday, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.\nWe believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. \nWe look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.\nTo apply\nPlease submit your application through our website and refer to Job ID 23388 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.","description_format":"text","description_chars":6399,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Equity","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-09-06T12:09:39Z"}],"visa":[],"liveness":{"score":39,"band":"fade","label":"Fading","p_open":1,"p_active":0.705,"p_room":0.55,"age_days":54,"expected_fill_days":42,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":103079,"is_top_pay":false},"html_url":"https://alion.io/job/abcellera-seniorstaff-engineer-pharmaceutical-delivery","json_url":"https://alion.io/job/abcellera-seniorstaff-engineer-pharmaceutical-delivery.json","meta":{"generated_at":"2026-10-27T01:47:38Z","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":843,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":179322},"rest":"https://alion.io/mcp/rest/get_company?id=179322"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabcellera-seniorstaff-engineer-pharmaceutical-delivery"},{"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%2Fabcellera-seniorstaff-engineer-pharmaceutical-delivery"},{"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%2Fabcellera-seniorstaff-engineer-pharmaceutical-delivery"},{"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/abcellera-seniorstaff-engineer-pharmaceutical-delivery\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabcellera-seniorstaff-engineer-pharmaceutical-delivery"}]}