Senior Technical Specialist, Engineering and Facilities

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.
• Support for Start Up & Continuous Production Activities: 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.
• Technical and Operational Guidance: Provide technical and operational guidance and recommendations in a professional and collaborative manner to internal and external stakeholders.
• Champion and Role Model: 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
• Highly collaborative with the ability to influence cross-functional teams without direct authority
• Takes initiative and recommends improvements to on-going processes and projects
• Identifies, and uses good judgement to handle out-of-compliance situations
• 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