By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.

Position Summary:

The QA Validation Engineer will work with suppliers and employee teams on the commissioning and qualification of a new GMP facility. This includes equipment IQ/OQ/PQ activities as well as validation and qualification of ISO 7 and ISO 8 cleanrooms. They will be responsible for ensuring all systems are running according to required specifications.

Role and Responsibilities

• Responsible for review of qualification and validation documentation, such as protocols, reports and SOPs fornew facilities/cleanroom validations/commissioning activities.

• Responsible for review of qualification protocols (IQ/OQ/PQ) and validation assessments for equipment used in manufacturing suites.

• Review of equipment user requirements.

• Responsible for ensuring validations are executed as per the procedures and protocols.

• Review and approve final validation/qualification packages.

• Execute protocols when required.

• Work with multiple groups (external and internal) in accomplishing the tasks assigned.

• Review vendor documents before and after qualification activities.

• Responsible for ensuring the validation documentation complies with both internal requirements and external regulations.

• Completing risk assessments to ensure equipment, systems, processes and facilities remain in a validated state.

• Conducting impact assessments, root cause analysis and resolution for validation deviations

• Monitoring any changes or maintenance to equipment and make the decisions on whether a full revalidation is required.

• Support in Change plans.

• Support with the environmental monitoring program as required.

• Mapping out the manufacturing processes and finding ways to improve processes.

• Project planning, scheduling and reporting, and working with the Project Manager to ensure delivery timelines are met.

Qualifications

Personal Qualities and Attributes:

• Excellent problem-solving, time management, and organizational skills, with good attention to detail.

• Self-motivated and conscientious, with a quality first and can-do attitude.

• Excellent communication skills with the ability to create solutions and communicate outcomes effectively with different audiences.

• Demonstrable ability to establish effective collaborative and operational relationships with diverse teams in Bio-Techne.

• Able to work to deadlines in a positive, flexible and pro-active way.

• Ability to engage respectfully with different points of view and to influence others.

Education and Experience:

• Bachelor’s Degree in science or engineering with experience in facilities and equipment validation.

• Experience of GMP manufacturing, facilities, equipment qualifications and process validations, including cleanrooms.

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

• Experience in commissioning of new buildings/facilities, including cleanrooms.

• Detailed knowledge of facility and equipment qualification processes.

• Demonstrated track record of high levels of personal and independent productivity.

• Possess excellent verbal and written communication skills.

• Good technical writing skills for drafting and revising validation SOPs that comply with both internal requirements and external regulations.

• Demonstrated collaborative and teamwork skills, with a high level of decision making and problem solving.

• Thorough grasp of H&S, quality, and SOP requirements.

Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.