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.
- 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).
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. This site is not accessible by public transportation options; daily, reliable transportation is needed to and from the site.
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.