Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The Senior Validation Engineer/Analyst functions as the lead for  maintenance, engineering, and validation activities within the assigned site/area of responsibility. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent is the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Manage departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services.
• Manage equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan (VMP) as appropriate. Responsible for Validation Change Control documentation and managing the electronic tracking system.
• Identify and implement opportunities to reduce costs, increase flexibility, and generate additional capacity through process improvement initiatives.
• Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
• Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
• Manage validation related, quality improvement projects to foster compliance to regulatory, corporate and department requirements.
• Represent department in quality audits, both internal and external, in regard to validation and engineering compliance.
• Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
• Partners with all levels of key business functions to ensure equipment has functionality and is equipped to support new and ongoing clinical studies.
• Conform to EH&S management system requirements and compliance obligations, promote continuous improvement and consider EH&S aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal and any program applicable according to the position duties.