Laboratory Operations Engineer

Merck & Co. • West Point, PA

323d • Onsite

About The Position

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.

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
• 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)

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, 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 development 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
• 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) 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

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree