Job Summary

BASIC SUMMARY:

Day to day duties as Validations Engineer for the Biologics Testing Solutions Division.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Writing, reviewing and executing validation documents.
• Liaising with the relevant Department Manager for the review of validations documents and prioritise validations projects.
• Liaise with the Validation Project Manager on Biologics Testing Solutions validation projects.
• Project Manage the full lifecycle for validation projects including but not limited to; delivering on time and to specification ensuring the delivery of a quality validation project within the Biologics business.
• Responsible for developing, preparing the installation of and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate, internal company standards and current industry standards.
• Write or assist in writing of SOPs for Validation Projects.
• Participate in validation project meetings, workshops, training of staff and production of related documentation.
• Present validation system programmes at internal and external audits as required.
• Provide progress reporting and input into established project documentation.
• Manage direct relationships with key project stakeholders.
• Perform duties in accordance with Standard Operating Procedures and with the principles of GMP according to the requirements of the assigned task. Ensure that all documentation is accurate and complete.
• Report any non-compliance to Quality Assurance, the Validation Manager, and to the relevant Department Manager.
• Develops and implements solutions to validation issues.
• Involvement in Lean Six Sigma projects to improve efficiencies in the Biologics Testing Solutions Division.
• Any other duties assigned by the Validation Manager as the role of Validations Engineer develops.

QUALIFICATIONS:

• Education: **Science Qualification or Equivalent
• Experience: 2 Years work experience
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure:
• Other:

PHYSICAL DEMANDS:

• Some light lifting
• Standing
• Flu vaccination may be required

WORK ENVIRONMENT:

• General Laboratory Environment

Job Qualifications