Lead Instrument Qualification Specialist

CBRE•Indianapolis, IN

About The Position

Full Spectrum Lab Services from CBRE offers a professional suite of services to a variety of clients in the life sciences industry, including those in pharmaceuticals, biotech, medical devices, and genomics, as well as contract research organizations (CROs) and contract manufacturing organizations (CMOs). Our comprehensive range of services includes laboratory consulting, real estate services, instrumentation repair and maintenance, full asset management, and more—covering the entire spectrum of life sciences facilities. With expertise across various life sciences categories, CBRE is a leader in managing highly-regulated spaces within the industry. About the role! The Lab Instrumentation Qualification Specialist provides support and technical expertise, assist in instrument acquisition, instrument management specific to the pharmaceutical research and development industry. The role also includes responsibility for activities such as establishing/complying with qualification strategies, entering change controls and deviations related to lab or instrumentation in the Quality tacking system, and continuous improvement. Maintenance of properly qualified equipment is of utmost importance within the regulated space. The LIS Specialist will assure optimum fulfillment of customer needs and compliance with regulatory, safety, privacy, and other applicable regulations.

Requirements

High School Diploma, GED, or trade school diploma with 5-8 years of job-related experience. In lieu of a diploma, a combination of experience and education will be considered.
Meet the physical requirements of this role including stooping, standing, walking, climbing stairs/ladders, and the ability to lift/carry heavy loads of 50 lbs. or more.
The innovative mentality to develop methods that go beyond existing solutions.
Ability to solve unique problems using standard and innovative solutions having a broad impact on the business.
In-depth knowledge of Microsoft Office products. Examples include Word, Excel, Outlook, etc.
Expert organizational skills with an advanced inquisitive mindset.
Highly sophisticated math skills.
Ability to calculate somewhat complex figures such as percentages, fractions, and other financial-related calculations.

Nice To Haves

Prior shift management or supervisory experience preferred.

Responsibilities

Complete complex documentation (instrument qualifications, change controls, Deviations) associated with work activities in a timely and accurate manner.
Become an area expert on requirements for good documentation practices.
Data support and reporting (CMMS data through business objects / SAVI reporting), providing quarterly work order review summary reports to management.
Coordinate qualification activities, Author / Update qualification documents.
Support instrument data archiving (software support) for decommissioning and retiring instrumentation.
Review contract maintenance strategy options for cost savings, self- perform vendor contract level evaluation.
Work with Global Data Stewards in ensuring workflow of documents is completed within Document Management System.
Through the Document Management System, workflow local instrument related documents and make updates as needed from SME and QA feedback.
Review service contract portfolio yearly to ensure accuracy and applicability.
Trackwise Change controls and deviations owner, responsible for investigations and ensuring the Change Control and/or Deviation is accurately documented.
Ensures utilities are in place to support operations, and that physical placement is suitable and environmental conditions support operation.
Ensuring that the equipment (including all necessary components), software, manuals, supplies, and any other accessories are present and undamaged.
Assist client with pre-planning activities of new instrument installs which could include working with third-part vendors, facilities, and project managers.
Initiate temporary vendor account via OPIMS for E3B systems.
Ensuring that all qualification activities are documented.
Performs asset decommissioning by having equipment removed from the lab and fills out or attaches proper documentation.
Address laboratory safety concerns (BSafe, Heads Up, CM work orders, etc.).
Performs semi-annual asset inventory.
Computer System Validation.
Assessments - instrument and Documentation Lead projects, providing technical leadership and supporting documentation of the initiative.
Serve as technical lead and subject matter expert (SME) for LIS, laboratory equipment qualification, and computerized systems validation.
Provide guidance, mentoring, and work direction to LIS Specialists and contractors; review work for accuracy, completeness, and compliance.
Act as primary owner for complex, high-impact, or escalated change controls, deviations, and investigations, including root cause analysis and CAPA development.
Lead cross-functional projects and initiatives, including global standardization efforts, system upgrades, lifecycle management strategies, and inspection readiness activities.
Establish and drive best practices, standard operating procedures, and documentation templates to ensure consistency and compliance across labs or sites.
Serve as key interface with Quality Assurance, IT, Facilities, Procurement, and external vendors for strategic planning, issue resolution, and implementation activities.
Own and manage metrics, trend analysis, and reporting, proactively identifying risks, gaps, and improvement opportunities.
Support and, when required, lead regulatory inspections and audits, including preparation, direct interaction with inspectors, and response development.
Drive continuous improvement initiatives, cost-savings strategies, and contract optimization related to laboratory instrumentation and services.