{"id":2667624,"url":"https://alion.io/job/keenova-senior-engineer-commercial-technical-operations","title":"Senior Engineer, Commercial Technical Operations","company":{"id":1880265,"name":"Keenova","domain":"keenova.com","url":"https://alion.io/company/keenova","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":4,"ghost_share":0,"stale_share":0.5,"repost_share":0,"time_to_fill_p50_days":51,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","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":{"min":80000,"max":129000,"currency":"USD","period":"year","gross":null,"usd_annual":129000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-10-13T00:00:00Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-11-03T05:05:35Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"description":"Job Title\nSenior Engineer, Commercial Technical Operations Requisition\nJR000016028 Senior Engineer, Commercial Technical Operations (Open)Location\nPhiladelphia, PAAdditional Locations\nJob Description Summary\nThe Senior Engineer, Commercial Technical Operations provides hands-on technical support and oversight for sterile drug product manufacturing across Keenova’s external manufacturing network. The role applies direct manufacturing experience in aseptic filling of vial and prefilled syringe presentations, with additional expertise in lyophilization, terminal sterilization, contamination control, and container closure integrity. The specialist serves as a practical interface between Keenova and contract manufacturing partners, supporting reliable supply, compliant execution, investigations, process and lifecycle improvements, packaging, and combination product assembly. This is a hybrid role based in the Philadelphia, Pennsylvania area, with regular travel to contract manufacturing sites, including but not limited to, locations in Washington State and Baltimore, Maryland.Job Description\nKey Responsibilities:\nProvide direct technical oversight and on-site support for commercial sterile drug product manufacturing at contract manufacturing organizations (CMOs).\nSupport aseptic filling operations for injectable presentations, including manufacturing readiness, batch execution, process monitoring, troubleshooting, and post-batch review.\nApply subject matter expertise in aseptic processing, cleanroom behavior, environmental and process controls, and EU GMP Annex 1 expectations.\nSupport lyophilization and terminal sterilization processes, including cycle execution, performance monitoring, technical assessment, and lifecycle improvement.\nLead or support technical investigations, deviation and CAPA development, root-cause analysis, change control, and implementation of sustainable corrective actions.\nDevelop, maintain, and improve contamination control strategies in partnership with Quality, Manufacturing, Microbiology, Engineering, and CMO teams.\nProvide technical support for container closure systems and container closure integrity testing (CCIT), including assessment of manufacturing or component changes and investigation of integrity-related issues.\nSupport technology transfer, process validation, continued process verification, process capability assessment, and manufacturing process improvements for sterile drug products.\nProvide technical support for combination products and self-injectable devices, including drug-device interface considerations, secondary or parenteral product packaging, device assembly, and associated manufacturing investigations and changes.\nAuthor, review or approve technical assessments, protocols, reports, investigation summaries, risk assessments, standard operating procedures, batch record changes, technical agreements and CMO governance materials.\nApply operational excellence methods, including Lean and Six Sigma tools, to improve process robustness, compliance, throughput, right-first-time performance, and cost effectiveness.\nProvide technical input to batch records, standard operating procedures, protocols, reports, risk assessments, technical agreements, and CMO governance materials.\nBuild effective working relationships with external manufacturing partners and internal stakeholders, communicate technical risks clearly, and escalate issues that may affect quality, compliance, supply, or patient use.\nMaintain current knowledge of relevant regulatory and industry expectations for sterile manufacturing and translate those expectations into practical manufacturing controls and improvements.\nQualifications:\nEducation / Experience / Skills:\nBachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or a related scientific or technical discipline required; advanced degree preferred.\nMinimum of seven years of direct, hands-on experience in sterile drug product manufacturing within a cGMP-regulated pharmaceutical or biopharmaceutical environment required.\nDemonstrated experience supporting aseptic filling operations for vials and/or prefilled syringes required; experience with both presentations preferred.\nWorking knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring interfaces, sterilization. and EU GMP Annex 1 required.\nWorking knowledge of appropriate regulations including 21 CRF 210 & 211, applicable USP guidance’s, EU GMP Annex 1 required.\nKnowledge of 21 CFR Part 4 & 820 an advantage.\nExperience with one or more of the following is strongly preferred: lyophilization, terminal sterilization, CCIT, manual visual inspection, combination products, or self-injectable device assembly.\nExperience supporting external or contract manufacturing sites, technology transfer, validation, continued process verification, investigations, CAPA, and change control preferred.\nExperience in parenteral product packaging and assembly operations preferred.\nWorking knowledge of risk-management and structured problem-solving tools, with demonstrated use of Lean and/or Six Sigma methods required; Green Belt or higher certification preferred.\nAbility to interpret manufacturing data, identify process trends, assess technical risk, and convert findings into clear, executable actions.\nExcellent written and verbal communication skills, sound technical judgment, and the ability to influence and collaborate across a matrix organization and with external partners.\nAbility to work independently in a remote environment, manage multiple priorities, and travel regularly to CMO locations.\nOrganizational Relationship/Scope:\nReports to Director, Commercial Technical Operations\nThis role is as an individual contributor within Technical Operations. The Senior Engineer works closely with Quality, Regulatory Affairs, Supply Chain, Engineering, External Manufacturing, and other portfolio or project teams. The role has no direct reports unless otherwise assigned but is expected to provide technical leadership and influence across matrix teams. Externally, the role is a key technical contact for CMO manufacturing, quality, engineering, validation, microbiology, packaging, and project teams. The role supports routine site engagement and governance, coordinates resolution of manufacturing issues, and helps ensure that agreed technical actions are implemented effectively.\nWorking Conditions:\nFully Remote\nKeenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova\nThe expected base pay range for this position is $80k- $129k. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.\nThis position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.\nDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.\nAt Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.\nWe bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.\nWe are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.","description_format":"text","description_chars":7986,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-16T03:14:10Z"}],"visa":[],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":0.9,"age_days":21,"expected_fill_days":51,"reasons":["conf:0","win:mid"],"computed_at":"2026-11-03T05:54:40Z"},"pay":{"stated_usd_annual":129000,"is_top_pay":false},"html_url":"https://alion.io/job/keenova-senior-engineer-commercial-technical-operations","json_url":"https://alion.io/job/keenova-senior-engineer-commercial-technical-operations.json","meta":{"generated_at":"2026-11-03T08:22:29Z","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":11957,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":1880265},"rest":"https://alion.io/mcp/rest/get_company?id=1880265"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkeenova-senior-engineer-commercial-technical-operations"},{"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%2Fkeenova-senior-engineer-commercial-technical-operations"},{"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%2Fkeenova-senior-engineer-commercial-technical-operations"},{"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/keenova-senior-engineer-commercial-technical-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkeenova-senior-engineer-commercial-technical-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2667624}},{"tool":"search_jobs","arguments":{"company":"keenova.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2667624},"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. 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