What are the responsibilities and job description for the Validation Engineer position at Research & Diagnostic Systems, Inc.?
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.
