{"id":1953752,"url":"https://alion.io/job/anter-consulting-operations-engineer-upstream","title":"Operations Engineer - Upstream","company":{"id":3802208,"name":"Anter Consulting","domain":"anterconsulting.com","url":"https://alion.io/company/anter-consulting","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":null},"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":["Singapore"],"countries":["SG"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":7000,"max":10000,"currency":"SGD","period":"month","gross":true,"usd_annual":93708},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"closed","first_seen_at":"2026-10-06T00:00:00Z","employer_posted_date":null,"last_verified_at":"2026-11-05T18:31:50Z","board_verified":false,"closed_at":"2026-11-05T18:31:50Z","days_open":30,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":30},"description":"Seeking an Operations Engineer specialising in upstream manufacturing to support a capacity expansion project at an established vaccine manufacturing facility in Singapore.\nThe successful candidate will support the introduction of new upstream equipment, materials and processes, working closely with manufacturing, engineering, automation and quality teams. This role involves hands-on commissioning, qualification, process validation and technical support within an operational GMP environment.\nKey Responsibilities\nSupport commissioning of upstream equipment, including bioreactors, media and buffer preparation vessels, process skids and transfer systems.\nParticipate in site acceptance testing, loop checks, equipment walkdowns and punch list resolution.\nExecute Installation Qualification and Operational Qualification protocols, document amendments and resolve qualification deviations.\nSupport commissioning and troubleshooting of Cleaning-in-Place and Sterilisation-in-Place systems, including interfaces with clean utilities.\nAssess and qualify new or alternative raw materials, media components, single-use consumables and filters.\nSupport material comparability and compatibility assessments, review supplier technical documentation and evaluate relevant extractables and leachables information.\nProvide technical support for seed train, cell culture, bioreactor operations and harvest activities.\nMonitor critical process parameters, review batch trends and investigate potential process performance issues.\nPlan and support engineering runs and trial batches, including sampling plans and acceptance criteria.\nAuthor and execute Process Performance Qualification protocols and prepare associated summary reports.\nSupport continued process verification as processes transition into routine manufacturing.\nInvestigate deviations and out-of-specification results, perform root cause analysis and drive corrective and preventive actions.\nManage change controls for equipment, materials and processes, including assessments of their impact on validated status.\nUpdate batch records, standard operating procedures and process documentation.\nCollaborate with vendors and internal stakeholders to support equipment handover, inspection readiness and compliant project delivery.\nRequirements\nBachelor’s degree in Chemical Engineering, Bioprocess Engineering, Biochemical Engineering, Biotechnology or a related discipline.\nAt least 3 years of relevant experience in GMP biologics or vaccine manufacturing, with strong knowledge of upstream processes.\nHands-on commissioning and qualification experience, including IQ/OQ execution for manufacturing process equipment.\nExperience authoring and executing process validation or PPQ protocols.\nDemonstrated experience in deviation investigations, root cause analysis and CAPA.\nWorking knowledge of change control and its impact on qualified equipment and validated processes.\nComfortable providing hands-on support on the manufacturing floor during commissioning and production runs.\nStrong technical writing, communication and cross-functional coordination skills.\nPreferred Experience\nRaw material or single-use consumable qualification, comparability studies or supplier change assessments.\nVaccine manufacturing, particularly recombinant or viral platforms.\nExpansion projects within an operating GMP facility.\nTechnology transfer or new product introduction.\nProcess data analysis using tools such as Minitab, JMP or PI.\nFamiliarity with DeltaV, Manufacturing Execution Systems or electronic batch records.\nSkills\nCoordination, Sourcing Raw Materials, Biochemical Engineering, Cleaning and Sterilising, Root Cause Analysis, Execute validation protocols, Installation Qualification, Production Support, Process Flows, Component Technology, Bioreactor Operation and Control, Acceptance Testing, Batch Management, Manufacturing Execution Systems, Chemical Engineering, Change Control Management","description_format":"text","description_chars":3946,"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":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Professional 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