Supervisor, Engineering Operations

Leadership And Engineering Operations Manager

Supervise day-to-day activities of Tier 1 and 2 support staff across second-shift operations. Train, mentor, and coach junior engineers on both technical troubleshooting and compliance-driven regulatory practices (GLP and GMP). Foster a culture of safety, accountability, continuous lean learning, continuous improvements, and regulatory discipline.

Provide hands-on support for laboratory / manufacturing instrumentation, automation platforms, and software systems (e.g., liquid handlers, NGS platforms, control software). Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with QMS and FDA expectations. Oversee incident triage, root cause analysis, CAPA, and track metrics (recurrence rate, closure time).

Lead the Engineering Operations team through the transition from LDT to FDA-regulated IVD environment, ensuring compliance with 21 CFR Part 820, ISO 13485, and Part 11 requirements. Establish and enforce formal change control processes for equipment modifications, repairs, and software updates. Collaborate with Quality and Regulatory Affairs to validate equipment (IQ / OQ / PQ) and document all maintenance and service activities in a compliant manner. Support FDA inspections, audits, and internal quality reviews by ensuring readiness of maintenance, calibration, and service records.

Identify and implement process improvements to optimize lab automation performance and uptime. Partner with R&D, Software, and Quality teams on system changes, new equipment validation, and controlled rollouts. Ensure vendor service activities are integrated into the QMS and supplier qualification processes.

4+ years of technical experience in engineering operations, automation support, or laboratory systems with BS / BA in Engineering, Life Sciences, or related field (or equivalent). 1+ years in a lead or supervisory role, with proven ability to train and mentor junior staff. Hands-on troubleshooting and repair of lab / manufacturing automation and sequencing systems (Hamilton, Tecan, Illumina, etc.). Familiarity with preventive maintenance, CMMS, EAM, calibration, and documentation practices in regulated environments (cGMP / GLP, CAP, CLIA). Strong communication skills and ability to lead in a cross-functional, fast-paced environment. Willingness to work on-call and support weekends / holidays. Experience with NGS workflows and Illumina sequencing platforms. Experience with Lean Manufacturing, 6-Sigma, equipment design and improvements. Knowledge of EAM / CMMS systems (Hexagon EAM preferred), LIMS, MES, and automation control software (e.g., Green Button Go). Background in change control, CAPA, and equipment validation (IQ / OQ / PQ). Experience guiding a team or organization through a regulatory transition (e.g., LDT to FDA-approved IVD, ISO 13485 implementation). Basic understanding of IT infrastructure and equipment networking.

Onsite, laboratory / manufacturing-based role requiring standing, walking, crouching, and PPE use. Must frequently lift and / or move up to 25 pounds; occasionally up to 50 pounds. Hours and days may vary depending on operational need - travel up to 10%.