About the role
Job Description
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.
* * 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).
Additional Information
Position is full-time, Mon-Fri 8am-5pm. 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.