Laboratory Operations Engineer

We have an exciting opportunity for a Laboratory Operations Engineer to join a growing team at a PSS Client site. 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

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• 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. Significant Safety or Working Considerations: 

• May come into contact with potentially infectious material.

• May handle hazardous chemicals

• Minimum of a Bachelor of Science in Engineering 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

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

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.