{"id":2571393,"url":"https://alion.io/job/abzena-project-engineer","title":"Project Engineer","company":{"id":2138905,"name":"Abzena","domain":"abzena.com","url":"https://alion.io/company/abzena","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":83,"open_postings":6,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":30,"computed_at":"2026-10-23T05:54:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bristol, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":55000,"max_usd":100000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4013},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-14T20:39:08Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-23T09:35:00Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"The Project Engineer is responsible for planning and executing site capital projects, equipment installations, facility upgrades, and engineering improvements that support Abzena's operations. The role provides end-to-end project engineering support from scope definition and business case development through design, procurement, construction, commissioning, qualification, startup, and turnover to operations.\nThe Project Engineer works closely with Manufacturing, Facilities & Engineering, Quality Assurance, Validation, EHS, Supply Chain, Finance, Process Development, Quality Control, Information Technology, contractors, architectural and engineering firms, and equipment vendors. The position is accountable for delivering technically sound, safe, compliant, and cost-effective solutions while controlling project scope, schedule, budget, risk, documentation, and operational readiness.\nResponsibilities\nManage assigned capital and expense projects from concept through closeout, including scope development, design, procurement, construction, commissioning, qualification, startup, and turnover.\nDevelop project charters, scopes of work, user requirements, project execution plans, cost estimates, schedules, risk registers, and resource plans.\nOwn project scope, schedule, budget, forecasts, commitments, change management, and financial tracking for assigned projects.\nCoordinate multidisciplinary project teams and drive clear accountability for milestones, decisions, actions, risks, and deliverables.\nLead or support engineering design reviews, constructability reviews, equipment selection, technical bid evaluations, and vendor selection.\nDevelop and review technical specifications, equipment requirements, drawings, layouts, P&IDs, utility requirements, and engineering deliverables.\nManage external engineering firms, contractors, construction partners, and equipment vendors to ensure work meets Abzena requirements, approved design, schedule, safety expectations, and GMP standards.\nPlan and support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, commissioning, and qualification activities.\nPartner with Validation and Quality to define risk-based commissioning and qualification strategies and ensure systems are appropriately qualified before GMP use.\nEnsure complete and compliant project turnover, including as-built drawings, manuals, spare parts, preventive maintenance requirements, calibration requirements, training, asset records, and system documentation.\nInitiate and support change controls, engineering assessments, deviations, CAPAs, investigations, and risk assessments associated with project execution and equipment or facility modifications.\nEnsure projects comply with cGMP requirements, Good Engineering Practices, data integrity expectations, applicable codes and standards, and Abzena quality systems.\nIntegrate EHS requirements into project design and execution, including contractor safety, permitting, job hazard assessments, lockout/tagout, and safe startup.\nCoordinate project activities with site operations to minimize disruption to manufacturing, laboratories, utilities, warehouses, and other critical functions.\nPlan and execute work during shutdowns, maintenance windows, and off-hours when required to protect manufacturing schedules and business continuity.\nSupport equipment and facility lifecycle planning by identifying reliability risks, obsolescence, capacity constraints, and improvement opportunities.\nApply structured problem-solving and root cause analysis to resolve technical issues encountered during design, installation, commissioning, qualification, and startup.\nDevelop and maintain project dashboards and KPIs covering safety, schedule, cost, scope, risk, quality, and readiness.\nProvide routine project status updates to site leadership, clearly communicating progress, decisions required, emerging risks, budget status, and recovery plans.\nSupport annual capital planning, project prioritization, business case development, and long-range site investment planning.\nIdentify opportunities to improve project delivery, engineering standards, equipment reliability, operational efficiency, capacity, and compliance.\nSupport client audits, internal audits, and regulatory inspections by providing project engineering documentation and technical subject matter expertise.\nPromote disciplined project execution, strong documentation practices, cross-functional collaboration, and a culture of safety, quality, and accountability.\nQualifications\nBachelor's degree in Mechanical, Chemical, Electrical, Industrial, Biomedical, or other relevant Engineering discipline required.\nMinimum 3 years of project engineering, capital project execution, facilities engineering, process engineering, or related experience in pharmaceutical, biotechnology, life sciences, or another highly regulated manufacturing environment.\nDemonstrated experience supporting projects through multiple lifecycle phases, including design, procurement, construction, commissioning, qualification, startup, and turnover.\nWorking knowledge of cGMP requirements, Good Engineering Practices, Good Documentation Practices, data integrity principles, and pharmaceutical quality systems.\nExperience with commissioning and qualification activities, including FAT, SAT, IQ, OQ, and risk-based qualification approaches.\nExperience with change controls, deviations, CAPAs, engineering assessments, and risk management in a regulated environment.\nWorking knowledge of pharmaceutical manufacturing equipment, cleanrooms, HVAC, critical utilities, process utilities, automation, or laboratory systems preferred.\nExperience developing or reviewing URS documents, scopes of work, technical specifications, drawings, P&IDs, and vendor documentation.\nDemonstrated ability to manage project budgets, schedules, forecasts, vendors, contractors, and competing priorities.\nStrong technical writing, analytical, troubleshooting, organizational, and structured problem-solving skills.\nStrong communication and stakeholder management skills with the ability to influence and coordinate cross-functional teams without direct authority.\nProficiency with Microsoft Office applications. Experience with project scheduling, CMMS, ERP, document management, or project controls systems preferred.\nExperience in a CDMO, biologics, ADC, bioconjugation, sterile manufacturing, or other complex GMP manufacturing environment preferred.\nProject management certification, Lean/Six Sigma training, or formal project controls experience preferred.","description_format":"text","description_chars":6579,"description_truncated":false,"requirements":{"experience_years_min":3,"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":["CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-10-14T23:02:10Z"}],"visa":[],"liveness":{"score":94,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.935,"p_room":1,"age_days":8,"expected_fill_days":30,"reasons":["conf:1","urgency","win:early"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/abzena-project-engineer","json_url":"https://alion.io/job/abzena-project-engineer.json","meta":{"generated_at":"2026-10-23T11:02:13Z","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":16770,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":2138905},"rest":"https://alion.io/mcp/rest/get_company?id=2138905"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabzena-project-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%2Fabzena-project-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%2Fabzena-project-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/abzena-project-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabzena-project-engineer"}]}