Main Purpose of Job and Objectives
As a Manufacturing Validation Engineer, you will be primarily accountable for the validation and validation maintenance of manufacturing processes, and test methods, manufacturing equipment and facilities.
Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives.
Perform validation of processes, equipment and facilities used in manufacture of medical devices to meet Regulatory requirements, this incorporates completion of validation protocol, installation qualification, operational qualification and performance qualification and supporting documentation.
Prepare and issue Validation Master Plans and schedules, summary reports and other required documentation for a validation exercise.
Organize and execute validation activities in order to provide an effective validation service.
Provide validation expertise to ensure that all operations are carried out in compliance with regulatory and company requirements.
Provide validation support and advice to other areas of the business as required.
Ensure projects relating to processes, facilities and equipment, are validated in line with regulatory and company requirements.
Provide specialist knowledge on process, facility, equipment issues within the site.
Promote effective working relationships and ensure they are maintained through the validation working party.
Support a continuous improvement culture within the business.
Provide guidance, and direction to staff consistent with ISO13485 and 21 CFR 820.
Develop work plans, assign tasks, and supervise teams as appropriate.
Ensure staff have appropriate knowledge and training on department and site, processes and procedures
Address site validation gaps via generation and completion of Validation Master Plans and schedules
Maintain site validation status according to regulatory requirements
Identify resource requirements and rate limiting steps within Validation Master Plan compliance
Support the provisions of quality data/reports/charts for the manufacturing group.
Generate relevant required documentation in support of regulatory updates and filings.
Perform any other duties/tasks/projects as require by management
Assume other responsibilities from time-to-time in order to support plant's strategic plan and personal career plans.
Responsible for archiving all Completed signed off validation documents into Iron Mountain boxes and sending them off site to Iron mountain
Qualifications and Experience
As a Manufacturing Validation Engineer you should be degree qualified with validation experience from within a scientific regulated environment. You will also be required to show evidence of the following:
A good working knowledge of ISO13485 and 21 CFR820
Experience in direct investigation/troubleshooting of validation problems
Experience in Analytical Test Method Validation
Experience in Equipment Qualification. Good statistical knowledge (DOE, capability studies, Gauge R&R, sample size definition, etc.)
Experience in the areas of qualification, analytical methods, lab equipment qualification, computer system validation, and requalification
Proficiency in Minitab and Microsoft packages will be a requirement
You will also be a natural influencer who is energetic in the pursuit of improved processes and innovative in developing solutions