Analytical Instrumentation Scientist

Position

The Analytical Instrumentation Scientist is responsible for coordinating the lifecycle management of analytical equipment across all laboratories. This role schedules and supports equipment installation, qualification, calibration, and preventive maintenance activities; ensures required documentation is completed accurately; and obtains the appropriate cross-functional approvals. The Analytical Instrumentation Scientist maintains complete and current equipment records, confirms that approved pre-execution protocols are in place before work begins, and coordinates completion and release of post-execution reports through the Quality Management System (QMS). This role serves as a central point of coordination among laboratory personnel, equipment vendors, and other stakeholders to support compliant equipment readiness and reliable laboratory operations.

Responsibilities

• Lead the technical oversight of analytical equipment lifecycle activities, including installation, qualification, calibration, preventive maintenance, repair, relocation, retirement, and associated equipment training activities to ensure compliance and operational effectiveness.
• Assess equipment lifecycle priorities and develop risk-based plans and schedules in coordination with laboratory personnel, Facilities, Engineering, Information Technology, Quality, vendors, and other stakeholders to support equipment readiness and regulatory compliance.
• Evaluate equipment performance, qualification status, and lifecycle risks and recommend actions regarding equipment readiness, remediation, and continued suitability for intended use.
• Author and revise equipment-related documentation and training materials, including qualification protocols, reports, risk assessments, procedures, work instructions, and associated controlled records.
• Apply scientific and technical expertise to determine qualification strategies, acceptance criteria, and equipment lifecycle requirements, ensuring approved protocols, work plans, permits, and supporting documentation are complete before activities are performed.
• Maintain complete, accurate, and current equipment records, including asset information, ownership, location, qualification status, calibration history, maintenance history, and related quality documentation.
• Coordinate the review, approval, execution, and archival of equipment lifecycle documentation through the Quality Management System (QMS), obtaining required cross-functional approvals as applicable.
• Ensure equipment qualification, calibration, and preventive maintenance activities are completed within established requirements and support deviations, investigations, CAPAs, change controls, audits, inspections, and periodic reviews associated with laboratory equipment.
• Ability and willingness to travel domestically to vendor or company sites, as needed, up to 20% of the time.

Early Development

After 3 months, you will: Complete required laboratory, Quality, safety, radiation safety, and equipment-related training. Develop a working knowledge of analytical equipment lifecycle processes and supporting documentation. Become proficient in equipment records, scheduling tools, and Quality systems used to support laboratory operations. Coordinate routine equipment activities and maintain equipment records with guidance.

After 6 months, you will: Independently coordinate routine equipment lifecycle activities, documentation, and stakeholder communications. Maintain accurate equipment records and proactively monitor qualification, calibration, and maintenance schedules. Ensure required approvals and documentation are in place before equipment activities are performed. Support equipment-related deviations, change controls, audits, and inspections as assigned.

Qualifications

MINIMUM EDUCATION/EXPERIENCE: Bachelor's degree in Chemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline and three (3) years of experience in a regulated laboratory, manufacturing, engineering, or equipment coordination role; or an equivalent combination of education and experience. Experience coordinating analytical equipment installation, qualification, calibration, or preventive maintenance activities is required.

PREFERRED EDUCATION/EXPERIENCE: Experience working in a cGMP or GLP environment is preferred. Familiarity with equipment lifecycle documentation, qualification protocols and reports, change control, deviations, computerized maintenance or asset management systems, and electronic Quality Management Systems is desired. Experience in radiopharmaceutical, pharmaceutical, biotechnology, or medical device operations is preferred.

PREFERRED CERTIFICATIONS: Certifications related to quality systems, equipment calibration, laboratory operations, or project coordination are preferred but not required.