Laboratory Operations Engineer

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
• Cook up 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
• Aid in the development of reporting, analytics and visualization solutions to support local clinical operations and administrative business processes
• Ensure automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirements
• Review 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
• Provide client services support for business area laboratory applications

Qualifications

• 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
• Required 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; 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)