Pharmaceutical Technical Writer Jobs in Raleigh, NC

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
• 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