Lab Operations Engineer

Eurofins•Spring House, PA

2d•Onsite

About The Position

Eurofins is seeking a Laboratory Operations Engineer to support process systems in clinical and non-clinical regulated bioanalytics laboratories at a PSS client site. The role supports laboratory automation assets, system security, data management, obsolescence initiatives, software development life-cycle activities, and compliance needs. It works with divisional and enterprise Information teams, global infrastructure, risk and security organizations, laboratory operations staff, vendors, service engineers, and facilities staff to support regulated laboratory programs. The engineer supports the full lifecycle of GxP equipment, from acquisition and installation through maintenance and retirement, and applies computer system validation expertise to laboratory equipment such as automated liquid handlers, plate readers, and PCR systems. The position maintains service schedules and instrument records, supports temperature-monitoring applications and controlled-temperature units, and helps ensure automation systems remain validated and compliant with current GxP requirements. It also contributes to continuous improvement, reporting and analytics, compliance support, audits, and training.

Requirements

Bachelor of Science degree and at least 2 years of relevant experience, or a master's degree in engineering science, Information Technology, or a related field.
Authorization to work in the country indefinitely without sponsorship.
Experience in a GLP or GMP laboratory, preferably in a bioanalytical setting.
Proven experience in validation activities and associated quality functions.
Strong interpersonal skills and the ability to influence others and promote inclusion, feedback, and empowerment.
Strong organization and multitasking skills to manage equipment or system schedules, documents, and maintenance tasks.
Strong verbal and written communication skills and comfort interacting with diverse on-site and off-site collaborators.
Ability to follow SOPs and contribute insight into continuous improvement.
General knowledge of company business developed through education or experience.
Ability to understand and apply regulatory and compliance requirements relevant to the role.
Problem-solving and troubleshooting skills, including Root Cause Analysis.

Responsibilities

Collaborate with divisional and enterprise Information teams, global infrastructure, and risk and security organizations to ensure compliant support of regulated bioanalytical laboratory programs.
Support the lifecycle of GxP equipment, including acquisition, installation, maintenance, and retirement.
Apply computer system validation expertise to diverse laboratory equipment, including automated liquid handlers, plate readers, and PCR systems.
Maintain instrument service schedules and ensure calibration and maintenance activities are completed on time in accordance with departmental SOPs.
Coordinate service activities with vendors, service engineers, and facilities staff.
Develop working knowledge of laboratory equipment such as liquid handlers, plate washers and readers, and PCR systems.
Serve as system administrator for equipment applications, including temperature-monitoring systems, and assist with controlled-temperature units and alarm handling.
Collaborate with laboratory operations staff across bioanalytical laboratories and sites on process improvement, cross-training, and cross-site support.
Support routine operations and promote continuous improvement.
Assist in developing reporting, analytics, and visualization solutions for local clinical operations and administrative business processes.
Maintain automation systems in a validated state through ongoing lifecycle management and compliance with current GxP requirements.
Review documents, preventive maintenance, and SOPs for compliance with GxP practices and corporate safety requirements.
Enhance the LAMP infrastructure used to track departmental equipment preventive maintenance.
Enter preventive and corrective maintenance services in the electronic laboratory logbook.
Oversee outsourced pipette calibration and maintain records in the electronic logbook.
Generate and review out-of-calibration impact reports, share them with management, and take appropriate action.
Perform Hamilton verification after preventive or corrective maintenance and document the verification in the electronic logbook.
Use technical knowledge to support efficient operation of automated processing and information technology systems.
Participate in compliance audits and training programs.
Provide client-services support for laboratory applications in the business area.