Senior Lab Support Engineer

Key Responsibilities

• Manage laboratory instruments lifecycle, including qualification, data integrity, maintenance, repairs, and decommissioning activities.
• Oversee instrument qualifications, collaborate with instrument owners, vendors and IT teams to configure systems and complete data integrity risk assessments within required timelines.
• Independently engage with instrument vendors to understand data flow, software features, data file generation, and 21 CFR Part 11 compliance capabilities of application software.
• Prepare data integrity risk assessments, configuration specifications, and qualification summary reports to ensure compliance for instrument release.
• Facilitate calibration, performance verification / maintenance and decommissioning activities.
• Review vendor-executed calibration, maintenance, repair, and performance verification tasks to ensure compliance with quality standards.
• Manage schedules to ensure timely completion of qualification, calibration, performance verification testing, and maintenance operations.
• Partner with the quality assurance (QA) team to ensure the accuracy and completeness of documentation while addressing and resolving compliance issues.
• Administer user account management activities, including handling password resets and account configuration requests.
• Verify and execute data backup and restoration tasks according to defined processes.
• Ensure timely resolution of quality events to maintain compliance with procedures.
• Participate in the development, update, or revision of Standard Operating Procedures (SOPs).

Education and Experience

The qualified individual must have a Bachelor of Science degree in chemistry, biology, computer science, or a related discipline, with 4-6 years of relevant qualification experience. Demonstrated knowledge of compliance requirements under cGMP and FDA regulations, including Good Documentation Practices (GDP) and laboratory GMP principles. Excellent attention to detail, organizational skills, and ability to create technical documents. Proven ability to work independently and collaboratively, with a results-oriented mindset and the ability to drive projects to timely completion. Customer-focused attitude and commitment to meeting deadlines. Self-motivated with a proactive approach to problem-solving and task ownership.

Knowledge, Skills and Abilities

• Proficient in instrument/equipment qualification, maintenance, and change control processes.
• Strong experience of 21 CFR Part 11 compliance pertaining to computer systems, including hardware, application software, and operating systems.
• Solid grasp of Data Integrity principles in a GxP environment.
• Experience in calibration, maintenance, and repair tasks for instrument lifecycle.
• Understanding of data file types generated by laboratory instruments and database structures.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.