Engineer I, MSAT

ElevateBio
Pittsburgh
Workplace: OnsiteFull timeFunction: Industrial, Process & Manufacturing EngineeringExperience: 3+ yearsEducation: bachelorsSkills: ["Technical writing","Root-cause analysis","Technical assessment","Cross-functional collaboration","Scientific methodology"]

Serve as the MSAT subject matter expert for GMP drug product manufacturing, supporting technology transfers, development studies, characterization, validation, and continuous improvement. You’ll collaborate across Process Development, Manufacturing, Supply Chain, Regulatory Sciences, and Quality to assess process changes, author/review cGMP technical documentation, troubleshoot on the floor, lead root-cause investigations for deviations, and contribute to process performance monitoring and process validation activities.

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FursaFursa
ElevateBio
ElevateBio
6 days ago

Engineer I, MSAT

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Source: Company careers pageValidated by: Fursa AI
Last checked: 8 hours agoStatus: Live

Job Summary

Serve as the MSAT subject matter expert for GMP drug product manufacturing, supporting technology transfers, development studies, characterization, validation, and continuous improvement. You’ll collaborate across Process Development, Manufacturing, Supply Chain, Regulatory Sciences, and Quality to assess process changes, author/review cGMP technical documentation, troubleshoot on the floor, lead root-cause investigations for deviations, and contribute to process performance monitoring and process validation activities.
Location: Pittsburgh
Workplace: Onsite
Employment Type: Full time
Job Function: Industrial, Process & Manufacturing Engineering
Seniority: Mid level

Key Responsibilities

  • •Represent MSAT on project teams as technical subject matter expert (SME) for drug product manufacturing.
  • •Provide technical assessment for technology transfers and process changes in a cGMP environment while working cross-functionally.
  • •Author and review technical documentation for manufacturing activities, including protocols, technical reports, batch records, SOPs, change controls, deviations, and regulatory submissions.
  • •Provide on-call or on-the-floor MSAT SME support for troubleshooting during cGMP manufacturing.
  • •Perform root-cause analysis for process-related deviations and support process validation, performance monitoring, and data-driven improvement projects.

Key Requirements

  • •BS/MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+/3+ years of relevant experience.
  • •Demonstrated pharmaceutical manufacturing knowledge for biotechnology products, including aseptic processing, cell culture, and process development.
  • •Practical expertise with cGMP manufacturing and regulatory requirements.
  • •Drug manufacturing experience, with LOVO, Sepax, Rotea, or CliniMACs devices and automated fillers preferred.
  • •Highly experienced leading investigations, writing deviation reports, change controls, and corrective actions.
Experience:3+ yearsBiotechnologyPharmaceutical manufacturingGMPAseptic processingCell cultureProcess validation
Education:Bachelor's in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology
Skills:Technical writingRoot-cause analysisTechnical assessmentCross-functional collaborationScientific methodology
Certifications:Certified Quality EngineerSix Sigma Green BeltSix Sigma Black Belt
Languages:English
Tech Stack:GMPCGMPAseptic processingCell cultureProcess validationLOVOSepaxRoteaCliniMACsAutomated fillersSOPsChange controlsDeviationsStatistical process controls

Company Brief

ElevateBio
Develops and manufactures cell and gene therapies and provides integrated biologics development and manufacturing platforms, partnering with biotech companies to accelerate clinical and commercial production of advanced therapies.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Cambridge, United States
Founded: 2017
WebsiteLinkedIn