Validation Engineer

Bio-Techne - Minneapolis, MN

Full-time - Entry Level

Minneapolis, MN

Chemical Manufacturing

About the position

The Quality Validation Engineer at Bio-Techne plays a crucial role in ensuring the quality and compliance of products through GMP qualification and validation processes. This position involves collaborating with a diverse team to support qualification and validation activities that lead to new product launches, emphasizing continuous improvement and adherence to regulatory standards.

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)

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
• 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

Nice-to-haves

• 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

Benefits

• Competitive wages
• Extensive benefits for employees and their families
• Retirement programs
• Employee stock purchase plan
• Career development through mentorship and training
• Promotional opportunities
• Internship programs
• International and diverse working environment
• Employee resource groups
• Volunteer and charity events
• Employee events that build a culture of caring and belonging
• Culture of empowerment and innovation