Lab Operations Engineer

Eurofins USA PSS Insourcing Solutions; Spring House (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a Laboratory Operations Engineer to support process systems in clinical and non-clinical regulated bioanalytical laboratories. You will help maintain validated automation, manage data, and coordinate with vendors and facilities to ensure GxP compliance across sites.

The role emphasizes lifecycle management, reporting and analytics, with opportunities to contribute to process improvements and training.

Qualifications

• Bachelor’s degree or Master’s in engineering, IT or related field with 2+ years of relevant experience.
• Authorization to work in the United States without sponsorship.

Responsibilities

• Support process systems in regulated bioanalytical laboratories.
• Maintain automation systems in a validated state per lifecycle and GXP requirements.
• Coordinate maintenance, calibration and service with vendors and facilities.
• Assist in reporting, analytics, and visualization for local operations.
• Participate in compliance audits and staff training.

Skills

GLP/GMP experience

Validation

Communication

Organization

SOPs

Regulatory compliance

Root Cause Analysis

Cross-site collaboration

Education

Bachelor's degree

Master’s degree in engineering/IT

Tools

LAMP infrastructure

Electronic lab logbook

LIMS (Laboratory Information Management Systems)

Job description

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, 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.