Laboratory Engineer

Catalyx is seeking a 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 automation asset maintenance, system security, data management, obsolescence initiatives and all SDLC and Compliance needs.

Job duties:

· 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) in PDMB Regulated BA.

· 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.

Requirements

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

· 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.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.