Supervisor, Engineering Operations (2nd Shift - Sun, Mon, Tues, Wed, 2:00 PM - 12:00 AM EST) #4265

Responsibilities:

• Leadership & Team Management
• Supervise day-to-day activities of Tier 1 & 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, continous leanring, continous improvments, and regulatory discipline.


• Technical Operations & Troubleshooting
• 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).


• Regulatory & Change Management
• 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.


• Continuous Improvement & Cross-Functional Collaboration
• 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.

Preferred Qualifications:

• 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.


• Highly Preferred
• 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.

Physical Demands and Working Environment:

• 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%.