QC Equipment Engineer

Neurotech Pharmaceuticals, Inc. is a private biotech company located in Cumberland, RI and Needham, MA, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech’s first commercial product, ENCELTO TM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases.

The QC Equipment Engineer (QC Metrology) is the single-point owner for the lifecycle management of Quality Control equipment and metrology systems across the QC organization. This role is responsible for ensuring QC instruments and supporting systems are specified, procured, installed, qualified, calibrated, maintained, repaired, and retired in a compliant and inspection-ready state.

This is a new position at Neurotech and will serve as the QC technical lead interfacing with Validation, Facilities/Engineering, Procurement, Quality Assurance, Logistics, and QC operational teams to execute and coordinate all activities required to keep QC equipment fit-for-use and available to support testing and operational needs. The individual is expected to operate independently, communicate clearly across functions and vendors, and maintain robust documentation, scheduling, and compliance controls. The role is onsite and includes vendor escort and coordination for service work.

Job Requirements

• Serve as QC SME for instrument readiness, ensuring equipment status supports routine testing, method execution, stability, investigations, and tech transfers.
• Maintain an accurate, inspection-ready inventory of QC equipment and metrology assets, including status, location, qualification state, calibration due dates, and service history.
• Own the QC metrology program and ensure:
• Calibrations are executed on time and aligned to criticality and intended use.
• Preventive maintenance (PM) schedules are established, executed, and documented.
• Out-of-tolerance (OOT) or calibration failures are assessed for impact to product/results and routed appropriately (QA/QC collaboration).
• Own QC equipment lifecycle from end to end and equipment records in the asset/calibration system (e.g., Blue Mountain), ensuring data accuracy and audit readiness.
• Ensure equipment labels/status controls are accurate and aligned with the system record (Qualified/Calibrated/Out of Service, etc.).
• Drive continuous improvement for scheduling with Facilities and Logistics, vendor performance, overdue prevention, equipment uptime, and documentation quality.
• Manage standards and reference materials where applicable (traceability, storage, use controls).
• Own the QC pipette program end-to-end:
• Inventory, assignment, and tracking by user/lab/area.
• Calibration schedules, rotation strategies, and spare coverage planning.
• Shipment coordination for offsite calibration vendors; packaging, chain-of-custody, and return verification.
• Investigation support for any pipette-related events (damage, failure, OOT, suspected drift), including impact assessment and documentation support.
• Partner with Validation to complete system assessments and execute qualification strategies for QC equipment (e.g., IQ/OQ/PQ as applicable). Ensure QC requirements are captured in URS/specifications and translated into qualification protocols and acceptance criteria.
• Support change control evaluations and impact assessments for equipment changes, upgrades, relocations, software/firmware updates, and vendor modifications.
• Maintain alignment between QC equipment state and validation/qualification documentation to ensure audit readiness.
• Coordinate onsite vendor visits, field service engineering work, repairs, and PM events:
• Schedule visits, confirm scope, ensure parts readiness, and coordinate lab access.
• Escort vendors onsite as required and ensure safety/GMP expectations are met.
• Review service documentation for completeness and compliance; ensure records are filed appropriately and deviations initiated when needed.
• Own vendor performance management for QC equipment service providers (responsiveness, quality of work, documentation quality, cost, recurring failures).
• Lead equipment purchasing activities in collaboration with Procurement:
• Develop technical requirements, evaluate vendors/quotes, and justify selection.
• Support PO creation, delivery planning, and installation readiness.
• Coordinate equipment receipt and onboarding with Logistics/Facilities/QC:
• Ensure proper receiving, inspection, labeling, and storage until installation.
• Establish asset records and ensure equipment enters the controlled system prior to use.
  

Education & Experience

• Bachelor’s degree in Engineering, Chemistry, Biology, Biotech, or related technical discipline (or equivalent experience).
• 5 years supporting laboratory equipment programs in GMP/regulated environment (biotech/pharma preferred).
• Demonstrated ownership of metrology/calibration/PM programs and equipment lifecycle management.
• Strong cross-functional communication skills with proven ability to manage vendors and drive work to closure independently.
• Experience with qualification documentation (IQ/OQ/PQ) and change control in a regulated setting.
• Comfortable working onsite in laboratories/controlled spaces and escorting vendors.
• Experience supporting QC instruments such as balances, pipettes, incubators, refrigerators/freezers, pH/conductivity meters, plate readers, ELISA platforms, cell counters, microscopes, autoclaves, biosafety cabinets, centrifuges, etc.
• Experience with CMMS/eQMS/LIMS asset modules (Blue Mountain, Maximo, SAP PM, MasterControl, TrackWise, etc.).
• Familiarity with data integrity expectations and equipment/software lifecycle considerations (access control, audit trails, backup/restore coordination where relevant).
• Ability to trend equipment downtime, recurring failures, vendor performance, and program KPIs.
  
  

Knowledge, Skills & Abilities

• Ownership mindset; executes independently and proactively.
• Excellent written and verbal communication; can translate technical issues into clear risk statements and action plans.
• Strong planning/scheduling discipline; prevents overdue calibration/PM and protects lab uptime.
• Vendor management and negotiation skills.
• Quality and compliance focus with strong documentation habits.
  
  

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.