Instrument Qualification Specialist - Pharmaceutical R&D Laboratory

CBRE • Indianapolis, IN

21d

About The Position

This is a strategic, high-visibility role at one of our largest pharmaceutical client sites. About the role The Instrument Qualification Specialist will provide support and technical expertise, and assist in instrument acquisition and 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 Instrument Qualification Specialist will assure optimum fulfillment of customer needs and compliance with regulatory, safety, privacy, and other applicable regulations.

Requirements

• High school diploma or general education degree (GED) required. Prefer a Bachelor's degree in chemistry, Engineering, or a related field OR significant pharmaceutical analysis, production, or maintenance experience.
• GMP documentation experience or equivalent
• Experience with use of computers and software packages (Trackwise, CMMS, Veeva/Q Docs, Teams)
• A strong understanding of chromatography principles
• CSV Background
• Technical writing skills
• Instrument interface and Networking (communication) skills
• Excellent written and verbal communication skills.
• Strong organizational and analytical skills.
• Ability to provide efficient, timely, reliable, and courteous service to customers.
• Ability to effectively present information.
• Requires knowledge of financial terms and principles. Ability to calculate intermediate figures such as percentages, discounts, and/or commissions. Conducts basic financial analysis.
• Ability to comprehend, analyze, and interpret documents.
• Ability to solve problems involving several options in situations. Requires intermediate analytical and quantitative skills.
• Superior attention to detail and problem-solving skills
• Teamwork and customer service-oriented mindset
• Strong communication skills, both oral and written
• Self-motivated, flexible and able to work independently.
• Ability to respond to changing priorities.
• Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.
• Applicant AI Use Disclosure We value human interaction to understand each candidate's unique experience, skills, and aspirations. We do not use artificial intelligence (AI) tools to make hiring decisions, and we ask that candidates disclose any use of AI in the application and interview process.

Nice To Haves

• Experience with Desktop publishing, Microsoft Office Suite, Advance excel knowledge would be beneficial.

Responsibilities

• Documentation 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. Store and archive documentation according to applicable procedures.
• Lab Equipment Management Provide support for laboratory operations to always ensure a state of compliance and inspection readiness. Data support and reporting (CMMS data through business objects / SAVI reporting), providing quarterly work order review summary reports to management. Provide NuGenesis Support as Power Users. Computer maintenance management system (CMMS) access and reporting ensuring the instrument data is accurate and searchable. Provide support for the Global Equipment Qualification Standardization project. Coordinate qualification activities, Author / Update qualification documents. Support instrument data archiving (software support) for decommissioning and retiring instrumentation. Instrument interface and Networking. Instrument Life Cycle Management 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, maintain 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.
• Other responsibilities: Trackwise Change controls and deviations owner, responsible for investigations and ensuring the Change Control and/or Deviation is accurately documented. Ensure utilities are in place to support operations, and that physical placement is suitable and environmental conditions support operation. Ensure that the equipment (including all necessary components), software, manuals, supplies, and any other accessories are present and undamaged. Ensure IQ/OQ/PQ protocols completed by CBRE technicians are second person verified (SPV) by Lilly personnel upon CBRE completion. 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. Ensure that all qualification activities are documented. Testing plan is executed. Results are documented. Results meet the acceptance criteria. Perform 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.). Attend monthly work order review meeting with Lab Operations and Quality Assurance. Route in document management system (Veeva Vault). Clearly label equipment with its status (e.g., Dot Not Use Tag) until maintenance activities are completed. Perform semi-annual asset inventory. Computer System Validation. Assessments - instrument and Documentation Lead projects, providing technical leadership and supporting documentation of the initiative.

Benefits

• CBRE is the premier provider of Laboratory Services. We offer excellent compensation and benefits, to include competitive salary, medical and dental benefits, PTO, 401K, and comprehensive training for professional growth.
• Benefits start 1st of the month following your hire date: medical, dental, vision, 401k, etc.
• First year of employment - 15 Days of PTO. Year 1 - 4 of employment 20 days of PTO!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees