Engineering Manager

About

We are seeking a Engineering Manager to lead and support the development, optimization, and maintenance of automated workflows for genomic assays, strengthening assay robustness, workflow efficiency, and data quality.

In addition to advancing automation solutions, this role supports the lifecycle of laboratory instruments by helping evaluate, introduce, and qualify new equipment in partnership with Facilities, IT, and asset owners—ensuring that tools required for automated workflows are properly specified, installed, and maintained throughout their use.

Key Responsibilities

• Design, script and optimize digital PCR protocols (liquid-class fine-tuning, labware teaching & optimization, error handling) in Hamilton Vantage/STAR platform.
• Plan and execute automated analytical method validation, data analysis and document per GAMP5 category 4 & 5.
• Troubleshoot and maintain automated systems to ensure optimal performance.
• Support method transfer of automated assays to Quality Control and external partners.
• Document automation procedures through SOPs, user manuals, and technical reports.
• Train laboratory personnel on automation systems and technologies.
• Manage the lifecycle of laboratory instruments, including evaluating new equipment with Facilities, IT, and asset owners, and completing equipment induction and enrollment in the CMMS.
• Assess facility, safety, and IT requirements—such as electrical needs, process gases, waste handling, software, data flow, and network connectivity for incoming equipment.
• Coordinate equipment procurement and setup by aligning specifications with suppliers, creating purchase orders, receiving and inspecting deliveries, and managing documentation and invoicing in Coupa.
• Serve as the main point of contact for equipment issues by coordinating service visits, overseeing IOQ activities, managing service contracts, and documenting all work performed in the CMMS.

Qualifications

• BS/MS in Bioengineering, Biotechnology, Mechanical Engineering, Electrical Engineering, or related field.
• 5+ years of hands-on experience with laboratory automation systems.
• In-depth expertise with Hamilton liquid handling platforms (Venus software preferred).
• Experience automating immunology and genomic workflows, aseptic mammalian cell culture, and dPCR on Hamilton Vantage/STAR.
• Author SOP/validation reports, and deviations/CAPA clearly and train cross-functional teams.
• Experience managing lab instrument lifecycle activities, including evaluating new equipment with Facilities, IT, and asset owners and completing induction/enrollment in the CMMS.
• Ability to coordinate equipment purchasing, setup, qualification, service visits, and CMMS documentation, including PO creation, receiving, and supplier interactions.

Preferred Qualifications

• Knowledge of cell therapy analytical development and manufacturing processes.
• Experience with DOE (Design of Experiments) approaches to method development.
• GAMP 5 and computer system validation expertise for lab automation.
• Knowledge of GMP regulations and experience working in a regulated environment.
• Experience with computer aided design tools (AutoCAD, Fusion or Fusion 360, etc.).
• Experience in LIMS (Benchling, Labguru, or similar) and its integration to lab automation scheduler.
• Experience using CMMS platforms such as Blue Mountain RAM, MasterControl, or Fiix for asset induction, maintenance tracking, and documentation.
• Familiarity with integrating laboratory equipment data and service records into a CMMS to support compliant, end‑to‑end instrument lifecycle management.