Engineering Technical Specialist

About the role

The Engineering Technical Specialist provides technical support for GMP and non-GMP operations, including Process Development, Clinical, and Manufacturing environments. This role is responsible for equipment validation, metrology, facilities maintenance, and electronic Quality Management System (eQMS) support to ensure equipment, systems, and procedures remain compliant, reliable, and operational. The position combines hands-on technical work, quality oversight, documentation development, and cross-functional collaboration to support manufacturing and facility operations in a regulated environment.

Responsibilities

• Develop and maintain validation and revalidation documentation, including User Requirements Specifications (URS), Risk Assessments, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Execute validation protocols, investigate deviations and non-conformances, and prepare final validation reports.
• Coordinate validation activities with internal stakeholders and external vendors to ensure timely execution and documentation closure.
• Review and approve validation protocols, reports, and validation summary packages.
• Provide oversight and coordination of vendor qualification activities when required.
• Coordinate calibration schedules with equipment and system owners to maintain compliance.
• Review and approve vendor calibration and certification documentation.
• Investigate and resolve equipment excursions and out-of-tolerance conditions.
• Perform basic calibrations when required, including temperature, pressure, and humidity-related equipment.
• Create, manage, and execute preventive and corrective maintenance work orders.
• Review and approve contractor and vendor service reports and maintenance activities.
• Support troubleshooting efforts and respond to building and equipment alarms as needed.
• Maintain equipment and system lifecycle data within the electronic Quality Management System (eQMS).
• Support onboarding, qualification, decommissioning, and retirement of equipment and systems.
• Identify opportunities to improve equipment lifecycle management, reliability, and compliance.
• Collaborate with Quality, Engineering, Manufacturing, Facilities, and external service providers to support operational objectives.

Requirements

• Minimum of 3 years of experience in a GMP-regulated manufacturing environment.
• Experience supporting equipment validation, qualification, or requalification activities.
• Strong technical writing experience, including protocol and report generation.
• Knowledge of IQ/OQ/PQ documentation and validation methodologies.
• Experience working with electronic Quality Management Systems (eQMS).
• Exposure to metrology and calibration programs.
• Ability to manage multiple projects and priorities simultaneously.
• Strong problem-solving and investigation skills.
• Experience supporting regulated manufacturing, laboratory, or pharmaceutical operations.
• Excellent communication and cross-functional collaboration skills.

Skills

• Equipment Validation (IQ/OQ/PQ)
• GMP Manufacturing
• Technical Writing & Protocol Development
• Metrology & Calibration Oversight
• Electronic Quality Management Systems (eQMS)
• Preventive & Corrective Maintenance
• Deviation Investigation & Resolution
• Cross-Functional Project Coordination

Qualifications

• Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related scientific discipline.
• Experience within biotechnology, pharmaceutical, cell therapy, gene therapy, or medical device industries is preferred.
• Familiarity with FDA regulations, GMP requirements, and quality systems.
• Experience coordinating vendor support activities and contractor oversight.
• Understanding of facility systems and equipment