By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Are you seeking to use your passion, vision, and creativity to make a difference in people’s lives? Do you view an innovation-driven opportunity as an investment in your future? Bring your talent to our Bio-Techne!

We are seeking an Advanced Quality Validation Engineer with experience in GMP qualification and validation. This position provides you an opportunity to work with a dynamic team with diverse experiences/backgrounds. You will support with qualification /validation activities leading to new product launches.

Quality is one thing Bio-Techne never compromises, and continuous improvements are key to our business. You have the opportunity to be part of this system.

Key Responsibilities:

• Responsible for the validation studies required for qualifying Manufacturing, Packaging equipment and Facility and Utilities, including: Classified areas, HVAC Systems for Clean Classified Areas, USP Water-for-Injection, Clean Compressed Air, and nitrogen.

• Support Media Fills - Protocols and reports generation.

• Support development and enhancement of Equipment Facility and Utility qualification programs in accordance with current data integrity and cGMP best practice expectations. Oversee management of qualification protocol development. Oversee applicable computerized system administration. Ensure compliance with FDA, USP, EU, federal and state agencies, and applicable global health authorities.

• Participate in development of risk based, quality driven procedures and practices with respect to engineering, qualification and validation. Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for the site.

• Participate in the development and execution of qualification protocols for facility systems, manufacturing equipment, and laboratory instruments.

• Assist in the identification, development, and implementation of new technologies to meet best practice expectations in the Manufacturing and Laboratory environments. Provide technical support for system owners and administrators for various facility systems, manufacturing equipment, and laboratory instruments.

• Support the change control program with respect to facility and equipment changes. Support the Information Technology change control program for computerized systems.

• Support the investigations program with respect to engineering, and qualification-related investigations, including trending and corrective and preventative actions.

• Ensure audit readiness in areas of responsibility at all times. Act as a subject matter expert during internal, customer and regulatory-body audits. As directed and when needed, interact with auditors to explain and/or clarify policies, procedures, and examples of equipment and computerized validations.

• Provide timely and effective completion of relevant activities in support of regulatory filings, production schedules and/or customer needs with respect to facilities, utility and equipment qualification.

• Perform technical review of qualification-related documentation. Provide training/guidance to Maintenance/Engineering, Manufacturing, and Laboratory personnel on relevant policies and SOPs.

• Collect and tabulate data, review data for errors and discrepancies, perform statistical analysis wherever appropriate and transcribe results into final reports.

• Generate, review, and approve qualification/validation procedures.

• Generate final reports, compile historical data packages, and route documents for approval.

• Review and approve set-up and operation procedures for production and packaging equipment.

• Generate risk assessments and technical memorandums to discuss the approach to qualification related activities.

• Support the rationale for the sample size selection during process equipment qualification.

• Review and complete assigned Change Control tasks.

• Initiate and manage Non-conformances, Change Control and CAPA processes.

• Participate/Perform Root Cause Analysis

• Assess risks in process/product and propose mitigation steps (ISO14971)

Qualifications and Education:

• Bachelor’s Degree in Engineering, Life Sciences or related discipline, with a minimum of 5-10 years of relevant experience performing validation activities within a pharmaceutical/ bio-technology environment; or equivalent combination of education and experience.

• Must possess knowledge of and adhere to Company and departmental policies and procedures, as well as government regulations.

• Must possess knowledge of current Good Manufacturing Practice (cGMPs), Annex 1, GAMP 5, 21CFR Part 210, Part 211, and Part 11. Knowledge of EudraLex - Volume 4 and World Health Organization (GMP) guidelines preferred.

• Understand the regulatory requirements (ISO9001, ISO13485, CFR210/211, ISO 14001)

• A background in pharmaceutical science or engineering, and equipment/computerized system validation is advantageous. Knowledge and understanding of pharmaceutical manufacturing equipment, facilities, and laboratory instrumentation preferred. Familiarity with Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control environments is advantageous.

• Must possess excellent organizational and deductive reasoning skills.

• Strong communication and written skills are required.

Knowledge, Skills, and Abilities:

• Knowledge of process equipment, such as bioreactors, chromatography systems, CIP, and autoclave

• Knowledge of biological process, such as fermentation, protein purification

• Experience with fill and finish of lyophilized materials

• Experience with cGMP manufacturing and clean utilities, such as clean steam, clean air, and WFI systems

• Knowledge of cGMP manufacturing regulations for the FDA, EU and other countries as required

• Assist in commissioning new buildings

• Software validation experience

• Understanding of equipment User Requirements/Risk Assessments

• Attention to detail required to determine adequacy of testing results

• Excellent computer skills