Laboratory Support Engineer

About the role

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.

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, 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

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)

Safety considerations

• May come into contact with potentially infectious material
• May handle hazardous chemicals
• This site is not accessible by public transportation options; daily, reliable transportation is needed to and from the site

Schedule

Position is full-time, Monday-Friday 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Spring House, PA are encouraged to apply.

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays