Senior Technical Specialist, Engineering and Facilities
Position Overview: The Senior Technical Specialist, Engineering and Facilities will report directly to the Sr. Director of Engineering & Facilities. Operating as a highly visible, cross-functional individual contributor under a centralized Shared Services Model, this role serves as the primary technical and engineering document resource across all four core pillars of the department: Capital Projects, Process Engineering, Automation & Controls, and Facilities & Maintenance.
This position will be critical to the operational readiness and sustainable compliance of our infrastructure for commercial operations. The Senior Technical Specialist will author, review, and champion complex lifecycle quality events and engineering documentation, acting as a collaborative bridge between Engineering, Manufacturing Operations, Process Development, Quality Control, and Quality Assurance. This role is ideally suited for a high-performing technical professional looking to maximize their organizational impact as an individual contributor, with a structured pathway to scale into a formal engineering management role as commercial operations expand.
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
Cross-Functional Liaison: Act as a main point of contact with our Process Engineering team to translate clinical-scale process parameters from the Process Development and MS&T teams into commercial engineering requirements, while partnering with Manufacturing Operations to minimize impact on production schedules
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
Audit Readiness & Defense: Maintain all engineering lifecycle documentation in an inspection-ready state, serving as a subject matter expert (SME) to defend technical engineering studies and deviation histories during internal and external health authority audits
Operational Tracking & Metrics: Trend engineering quality indicator data, monitoring lifecycle metrics for aging change controls and deviations to promote continuous operational improvement
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
Provides technical and operational guidance and recommendations in a professional and collaborative manner to internal and external stakeholders
Champions and role models Beam’s Leadership Behaviors and Values
Qualifications: Knowledge of science and engineering principles attained through studies resulting in a B.S. in engineering, biochemistry, or a closely related discipline preferred
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
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.
Working knowledge of validation and related concepts, lifecycle management, and risk-based validation approach
Problem solving and autonomy: independently troubleshoot complex problems and lifecycle documentation bottlenecks, demonstrating consistent judgment, speed, accuracy, and creativity
Exceptional listening, negotiation, and communication skills
Beam Therapeutics is hiring for this role on CareerPlace.
Apply on the company website through Beam Therapeutics.
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