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 a 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:  

Draft and review qualification/validation protocols (IQ/OQ/PQ/PV/others) 

Draft/Revise and review Standard Operating Procedures (SOPs)  

Review calibration records and handle Impact Assessments in Regulatory Asset Manager 

Identify gaps and improve processes 

Manage protocol approvals in eDMS 

Provide quality guidance to departments to fulfill regulatory and process requirements 

Support various departments in achieving their qualification/validation needs 

Develop a good understanding of the manufacturing processes and equipment  

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

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/Requirements:  

cGMP background/understanding is critical for this role 

Background in life sciences is preferred 

Analytical thinking required to plan validations and analyze outcomes 

Cleaning Validation and Computer System Validation experience is a great add-on  

Ability to work in team and independently is important 

Engaging with cross-functional groups to meet project goals 

Good communication skillset is key 

Education and Experience:

Bachelor's degree in a science or engineering discipline with a minimum of 1-5 years’ experience in qualification/ validation.  

Experience in equipment qualification and validation process 

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  

Why Join Bio-Techne:

We offer competitive wages along with extensive benefits for employees and their families.We invest in our employees’ financial futures through retirement programs and an employee stock purchase plan.We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.

Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.