Senior Technical Specialist, Engineering and Facilities

Senior Technical Specialist, Engineering and Facilities

Work Location: Durham County, North Carolina

Summary:

This position serves as a key technical resource within engineering and facilities, supporting operational readiness and compliance for commercial operations. The role involves authoring and reviewing complex engineering documentation, leading investigations, and acting as a bridge between multiple technical and quality teams. The position offers a pathway to future engineering management roles as operations expand.

Responsibilities:

• Develop, review, and manage critical technical documents such as engineering studies, technical summaries, user requirement specifications, and validation packages to ensure alignment across all product lines.
• Lead and resolve engineering-related deviations, CAPAs, and change controls, ensuring compliance with internal procedures and regulatory standards.
• Conduct advanced root cause analyses for facility and equipment issues using formal investigation tools.
• Serve as a liaison to translate process parameters into commercial engineering requirements and collaborate with operations to minimize production impact.
• Facilitate and document risk management assessments and FMEAs to ensure robust quality and contamination controls in engineering assets.
• Draft, review, and optimize standard operating procedures for engineering, maintenance, and calibration to support commercial readiness.
• Maintain engineering documentation in an inspection-ready state and act as a subject matter expert during audits.
• Monitor and trend engineering quality metrics, tracking lifecycle data to drive continuous operational improvement.

Qualifications:

• Bachelor’s degree in engineering, biochemistry, or a closely related discipline preferred.
• 12+ years of relevant experience in biotech, pharmaceutical, or GMP manufacturing environments, with emphasis on technical engineering writing, asset lifecycles, or engineering compliance.
• Demonstrated expertise in technical writing, with experience drafting and reviewing complex engineering documents for accuracy and regulatory compliance.
• Strong knowledge of clean utilities, HVAC design, automation and controls systems, and multimodality cell and gene therapy or aseptic processing preferred.
• Proficiency in Microsoft Word, Excel, PowerPoint, Smartsheets, Veeva QDocs, Veeva QMS, and Kneat; knowledge of DeltaV, Disego, OSI PI, BlueMountain RAM/CMMS, and similar applications highly desirable.
• Understanding of validation concepts, lifecycle management, and risk-based validation approaches.
• Ability to independently troubleshoot complex problems and documentation bottlenecks, demonstrating sound judgment, speed, accuracy, and creativity.
• Exceptional listening, negotiation, and communication skills, with a collaborative approach and ability to influence cross-functional teams.
• Initiative to recommend process and project improvements, and sound judgment in handling out-of-compliance situations.
• Willingness to work a flexible schedule, including support for critical operations outside normal hours as needed; facilities and maintenance coverage is 24/7.

Published Category: Manufacturing & Technical Operations