Laboratory Operations Engineer

Job Description

Job Description:

The Laboratory Operations Engineer in the Discovery, Preclinical and Translational Medicine Operations organization will be responsible for supporting process systems in clinical and non-clinical Regulated Bioanalytics laboratories. This position may provide direct support to asset maintenance, system security, data management, obsolescence initiatives and all SDLC and Compliance needs.

Job duties include:

• 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, install, 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 LC-MS 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 LC-MS.

• 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 support, promoting a culture of continuous improvement.

• Assist in the developement of reporting, analytics and visualization solutions to support local clinical operations and administrative business processes.

• Ensure systems remain in a validated state as part of an ongoing lifecycle management program, compliant with current GxP requirements.

• Coordinate scheduling with end-users for LC and mass spectrometry systems to address arising issues.

• 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) in PDMB Regulated BA.

• Provide compliance support activities such as entering PM and corrective maintenance services in the electronic laboratory logbook (Signals).

• 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.

Education:

• Bachelor's (with at least 2 years of relevant experience) or a master’s degree in engineering, Science, Information Technology, or a related field.

Required experience and skills:

• 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.

• Follow Standard Operating Procedures with insight for continuous improvement.

• Applies general knowledge of company business developed through education or experience.

• Understands and applies regulatory/ compliance requirements relative to their role.

• A problem solver/troubleshooter, skilled in Root Cause Analysis (RCA).

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