Laboratory Operations Engineer

Eurofins•Spring House, PA

5d•Onsite

About The Position

We have an exciting opportunity for a Laboratory Operations Engineer to join a growing team at a PSS Client site. The Laboratory Operations Engineer will be responsible for supporting process systems in clinical and non-clinical Regulated Bioanalytics laboratories. This position may provide direct support to automation asset maintenance, system security, data management, obsolescence initiatives and all SDLC and Compliance needs.

Requirements

Minimum of a Bachelor of Science degree needed (with a minimum of 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.
Demonstrated strong interpersonal skills with the ability to influence others and promote a culture of inclusion, feedback, and empowerment.
Highly organized, and multitasking capabilities to manage multiple equipment or system schedules, documents, and maintenance tasks.
Strong verbal and written communication skills, with comfort in interacting with diverse on-site and off-site collaborators.
Ability to follow Standard Operating Procedures with insight into continuous improvement.
Apply general knowledge of company business developed through education or experience.
Understand and apply regulatory/ compliance requirements relative to the role.
Problem solver/troubleshooter, skilled in Root Cause Analysis (RCA).

Responsibilities

Collaborate with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure compliant laboratory support of regulated bioanalytical laboratory programs
Support the lifecycle of GxP equipment including the acquisition, installation, maintenance, and retirement phases.
Apply deep expertise in the computer system validation process for diverse laboratory equipment such as automated liquid handlers, plate readers, and PCR systems.
Maintain service schedules for instrument maintenance, ensuring timely completion of calibration and maintenance activities in accordance with departmental SOPs.
Coordinate service activities involving various vendors, service engineers, and facilities staff, fostering strong professional relationships.
Develop a working knowledge of laboratory equipment, like liquid handlers, plate washers/readers, and PCR.
Serve as system administrator for equipment applications, including temperature monitoring systems, assisting in the management of controlled temperature units and alarm handling.
Collaborate with lab ops staff across bioanalytical labs and sites for process improvement, cross-training and cross-site support.
Engage in the routine operations supports promoting a culture of continuous improvement.
Assist in the development of reporting, analytics and visualization solutions to support local clinical operations and administrative business processes.
Ensuring automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirements.
Reviewing documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with GxP Practice and corporate safety requirements.
Enhance the existing LAMP infrastructure to track equipment preventative maintenance (PM) within the client’s department.
Provide compliance support activities such as entering PM and corrective maintenance services in the electronic laboratory logbook.
Oversee outsourced pipette calibration, maintaining records in the electronic logbook. Generate and review out-of-calibration impacts reports, share it with management and take appropriate actions.
Perform Hamilton verification after PM/CM, documenting verification in the electronic logbook.
Utilize technical knowledge to ensure efficient operation of various automated processing and informational technology systems.
Participate in compliance audits and training programs.
Providing client services support for business area laboratory applications.