Beam Therapeutics

Beam Therapeutics

Senior Technical Specialist, Engineering and Facilities

Durham, NC · Senior · Full-time

Sponsorship not specified$140k-$185kDetected 19 hours ago
NegotiationExcelGMPCRISPRLeadershipCommunicationProblem SolvingWritingMicrosoft Office

About the role

  • Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
  • To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
  • This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.

Responsibilities

  • Centralized Documentation Authoring: Support the entire Engineering & Facilities team by authoring, reviewing, and shepherding critical technical documents-including engineering studies, technical summaries, user requirement specifications (URS), functional specifications, and validation/engineering turn-over packages (ETOP)-ensuring cross-functional alignment across all product lines
  • Lifecycle Quality Events: Initiate, investigate, and drive to completion engineering-related deviations, Corrective and Preventive Actions (CAPAs), and complex Engineering Change Controls (ECC) to meet stringent internal procedures and regulatory expectations
  • Advanced Root Cause Analysis: Lead technical investigations for facility-wide and equipment-specific issues (e.g., clean utility continuous monitoring alerts, HVAC excursions, or automated process equipment failures during a run) using formal root cause analysis tools
  • Risk Management & Quality by Design: Facilitate and document Quality Risk Management (QRM) assessments and Failure Mode and Effects Analyses (FMEAs) to ensure robust quality and cross-contamination mitigations are built into multi-modality engineering assets from the beginning
  • Standard Operating Procedures: Draft, review, and optimize engineering, maintenance, and calibration SOPs as the site advances its commercial operational readiness
  • Provide support for all related start up and continuous production activities related to operational readiness including, but not limited to, procedure creation, equipment qualification and validation
  • Support the entire Engineering & Facilities team by authoring, reviewing, and shepherding critical technical documents-including engineering studies, technical summaries, user requirement specifications (URS), functional specifications, and validation/engineering turn-over packages (ETOP)-ensuring cross-functional alignment across all product lines
  • Initiate, investigate, and drive to completion engineering-related deviations, Corrective and Preventive Actions (CAPAs), and complex Engineering Change Controls (ECC) to meet stringent internal procedures and regulatory expectations
  • Facilitate and document Quality Risk Management (QRM) assessments and Failure Mode and Effects Analyses (FMEAs) to ensure robust quality and cross-contamination mitigations are built into multi-modality engineering assets from the beginning

Requirements

  • 12+ years of relevant experience in a biotech, pharmaceutical, or GMP manufacturing environment with a heavy emphasis on technical engineering writing, asset lifecycles, or engineering compliance
  • Working knowledge of validation and related concepts, lifecycle management, and risk-based validation approach
  • Highly collaborative with the ability to influence cross-functional teams without direct authority
  • Technical writing with proven experience in drafting and reviewing highly complex technical engineering documents with a keen eye for technical accuracy, clarity, and regulatory compliance.
  • Knowledge of clean utilities, HVAC design, automation and controls systems, and multimodality cell and gene therapy / aseptic processing is strongly preferred
  • Proficient in Microsoft Word, Excel, PowerPoint, Smartsheets, Veeva QDocs, Veeva QMS and Kneat. Preferred knowledge of DeltaV (PCS), Disego (BAS), OSI PI, BlueMountain RAM / CMMS, and other applications are highly desirable.

Nice to have

  • Knowledge of science and engineering principles attained through studies resulting in a B.S. in engineering, biochemistry, or a closely related discipline preferred
  • Proficient in Microsoft Word, Excel, PowerPoint, Smartsheets, Veeva QDocs, Veeva QMS and Kneat.
  • Preferred knowledge of DeltaV (PCS), Disego (BAS), OSI PI, BlueMountain RAM / CMMS, and other applications are highly desirable.

Compensation

  • The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.

Benefits

  • Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
  • Must be willing to have a flexible schedule during process start up and manufacturing runs, which may include supporting critical operations outside of normal work hours, as needed.
  • Facilities and Maintenance team provides 24/7 site coverage
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This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.