Documentation Qualification Specialist - Pharmaceutical Lab

CBRE; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

CBRE's Full Spectrum Lab Services unit seeks an experienced professional to support pharmaceutical research and development environments. You will manage instrument qualification activities, update procedures, and help ensure inspection readiness in highly regulated settings.

Coordinate qualification tasks, author and update qualification documents, and support data archiving and change controls. You will verify IQ/OQ/PQ protocols, ensure documentation accuracy, and help drive compliant outcomes

Qualifications

• High School Diploma, GED, or trade school diploma with 5-8 years of related experience.
• Knowledge of setup, operation, and maintenance of HPLC/UPLC instrumentation.
• Ability to lift 50 lbs and perform physical tasks as required.
• Innovative mindset to develop methods beyond existing solutions.
• Strong problem-solving with broad business impact.
• Proficiency in Microsoft Office (Word, Excel, Outlook).
• Highly organized with an inquisitive mindset.
• Strong math skills for percentages and ratios.

Responsibilities

• Review and update equipment, maintenance, and calibration procedures.
• Complete complex documentation (instrument qualifications, change controls, deviations) accurately.
• Provide support for laboratory operations ensuring compliance and inspection readiness.
• Coordinate qualification activities and author/update qualification documents.
• Support instrument data archiving and tracking change controls; manage deviations.
• Ensure IQ/OQ/PQ protocols are SPV by client personnel.
• Confirm that all qualification activities are documented.
• Test plans executed and results documented to meet acceptance criteria.
• Apply chromatography principles to interpret chromatogram abnormalities.
• Ensure programs and procedures are followed per client scope.
• Manage contractor specifications and performance.
• Verify compliance with safety, regulatory and company policies.
• Show initiative to develop new methods; lead by example.
• Communicate complex ideas effectively and influence stakeholders.

Skills

HPLC/UPLC knowledge

MS Office

Math skills

Problem solving

Organizational skills

Education

High School Diploma or GED

Tools

HPLC/UPLC instrumentation

Job description

• Coordinate qualification activities, Author / Update qualification documents.

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

In this role you will provide support, technical expertise, assist in instrument acquisition, instrument management specific to the pharmaceutical research and development industry.

This job is part of the Critical and Technical Services job function. They are responsible for technical maintenance services in critical client environments.

What You’ll Do

• Review and update equipment, maintenance, and calibration procedures.
• Complete complex documentation (instrument qualifications, change controls, Deviations... ) associated with work activities in a timely and accurate manner.
• Provide support for laboratory operations to always ensure a state of compliance and inspection readiness.
• Coordinate qualification activities, Author / Update qualification documents.
• Support instrument data archiving (software support) for decommissioning and retiring instrumentation. Trackwise Change controls and deviations owner, responsible for investigations and ensuring the Change Control and/or Deviation is accurately documented.
• Ensure IQ/OQ/PQ protocols completed by CBRE technicians are second person verified (SPV) by client personnel upon CBRE completion.
• Ensuring that all qualification activities are documented.
• Testing plan is executed.
• Results are documented.
• Results meet the acceptance criteria.
• Apply chromatography principles to interpret abnormalities in the chromatogram peak shape, retention time, and baseline.
• Implement client scope of services and ensure all programs and procedures are being properly followed.
• Manage contractor specifications, problems/issues, performance, and administration.
• Verify compliance with performance, safety, statutory, and regulatory requirements, and company policies, standards, and procedures.
• Apply advanced knowledge to seek and develop new, better methods for accomplishing both individual and department objectives.
• Showcase expertise in own job discipline and in-depth knowledge of other job disciplines within the organization function.
• Lead by example and model behaviors that are consistent with CBRE RISE values. Anticipates potential objections and persuades others, often at senior levels and of divergent interest, to adopt a different point of view.
• Impact the achievement of customer, operational, project, or service objectives across multi-discipline teams. Work is guided by functional policies which impact the design of procedures and policies.
• Contribute to new products, processes, standards, and/or operational plans in support of achieving functional goals.
• Communicate difficult and complex ideas with the ability to influence.

What You’ll Need

• 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. Prior shift management or supervisory experience preferred.
• Knowledge of setup, operation, and maintenance of HPLC/UPLC instrumentation
• 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.

Why CBRE?

When you join CBRE, you become part of the global leader in commercial real estate services and investment that helps businesses and people thrive. We are dynamic problem solvers and forward-thinking professionals who create significant impact. Our collaborative culture is built on our shared values - respect, integrity, service and excellence and we value the diverse perspectives, backgrounds and skillsets of our people. At CBRE, you have the opportunity to chart your own course and realize your potential. We welcome all applicants.

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.

Disclaimers: Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.

Equal Employment Opportunity: CBRE is an equal opportunity employer that values diversity. We have a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.

Candidate Accommodations: CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company’s success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at [e-mail] or via telephone at [phone] (U.S.) and [phone] (Canada).