Our client is seeking to hire an experience
Validation Engineer
to join their team.
Responsibilities
Write, review, and approve validation documentation to ensure continuity in the validation program for the assigned plant or functional area.
Other duties may be assigned.
Ensure that the validation requirements are documented to provide direction for meeting the validation needs of customers, regulatory bodies, manufacturing plants, research and development, IT, and laboratory groups.
Provide guidance to system/process stakeholders for validation documents, as to content and format of validation life cycle documentation.
Write protocols and reports directly related to QA, e.g. (statistical sampling plans, assessment criteria (Validation Rationale), compliance, guidelines, specifications, etc.
).
Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports.
Guide protocol incident process, including reporting, investigations and approval of resolutions.
Utilise engineering, vendor, and customer specifications to generate and execute testing protocols for equipment following customer procedures and good documentation practices.
Strong attention to detail and knowledge of pharmaceutical processes and protocols around automation processes, equipment, and systems.
Keep current with the industry standard practices and FDA requirements for validation.
Write/revise validation templates and validation plans.
Experience
Minimum Bachelor of Science Degree in Engineering or Science.
Minimum 7 years of experience writing, approving and executing validation protocols and reports, specifically in the following areas:
Process Validation
Equipment/Utility
Qualification
Automation
Ability to comprehend computer systems applications and business/manufacturing processes.
Excellent written and verbal communication skills, good problem-solving skills, and ability to function as a team member and leader.
To discover more about this opportunity, apply now or contact Lewis Murray in HRM Search Partners on for a confidential discussion.
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