Laboratory Operations Engineer

About the role

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.

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, 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 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 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 them 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.

Significant Safety or Working Considerations

• May come into contact with potentially infectious material.
• May handle hazardous chemicals.

Requirements

• 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.

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, with 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).

Schedule

Position is full-time, Monday-Friday 8am-5pm with overtime as needed.

Benefits

• 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.

Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.