With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Metrology & Systems Lead is responsible for overseeing Abzena's calibration, metrology, computerized maintenance management systems (CMMS), and engineering systems administration programs. This role ensures the reliability, accuracy, compliance, and lifecycle management of instruments, monitoring systems, asset records, maintenance systems, and engineering data. The position serves as the primary subject matter expert for calibration compliance, CMMS administration, asset management, engineering documentation, and facility systems reporting.

The Metrology & Systems Lead collaborates with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Facilities, and Information Technology to ensure systems remain compliant, inspection-ready, and capable of supporting GMP operations.

Responsibilities

Lead and administer the site calibration and metrology program to ensure compliance with GMP requirements and regulatory expectations.
Develop, maintain, and continuously improve calibration procedures, schedules, standards, and documentation.
Serve as system administrator for the CMMS and related engineering systems.
Maintain equipment asset records, preventive maintenance schedules, calibration schedules, and system master data.
Coordinate calibration activities performed by internal personnel and external vendors.
Review calibration records, maintenance records, work orders, and system documentation for accuracy and compliance.
Ensure timely completion of preventive maintenance and calibration activities for GMP and non-GMP assets.
Support deviation investigations, CAPAs, change controls, and root cause analyses involving calibrated instruments and engineering systems.
Manage engineering data integrity within CMMS, environmental monitoring systems, building management systems, and other facility-related computerized systems.
Generate and analyze metrics related to calibration compliance, preventive maintenance performance, asset reliability, and engineering effectiveness.
Support regulatory inspections, client audits, and internal audits by providing engineering systems and calibration documentation.
Maintain equipment hierarchies, asset classifications, spare parts data, and maintenance strategies within CMMS.
Support qualification and validation activities for engineering systems, computerized systems, utilities, and facility equipment.
Develop and maintain engineering reports, dashboards, KPIs, and compliance metrics.
Identify opportunities to improve maintenance effectiveness, asset reliability, system utilization, and regulatory compliance.
Support capital projects by coordinating asset setup, documentation management, calibration requirements, and maintenance planning.
Serve as the site subject matter expert for calibration standards, metrology practices, and engineering systems governance.

Qualifications

Associate's or Bachelor's degree in Engineering, Engineering Technology, Facilities Management, Instrumentation, Industrial Technology, Computerized Systems, or related discipline preferred.
Minimum 3 years of experience in calibration, metrology, maintenance systems administration, engineering systems management, or regulated manufacturing environments.
Experience administering CMMS platforms, asset management systems, or engineering databases.
Strong knowledge of calibration principles, metrology standards, instrumentation, and measurement systems.
Knowledge of GMP regulations, FDA requirements, data integrity principles, and pharmaceutical manufacturing environments.
Experience supporting deviations, CAPAs, change controls, audits, and regulatory inspections.
Strong analytical, organizational, and problem-solving skills.
Advanced proficiency in Microsoft Excel, reporting tools, and computerized maintenance systems.
Ability to communicate effectively across all levels of the organization.
Experience with computerized systems validation (CSV), environmental monitoring systems, building management systems, or facility monitoring systems preferred.

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.