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The Validation Engineer will work within a team of 8 that design and perform validation activities associated with new installation projects (Equipment / Facilities / Utilities / Systems), to the existing manufacturing process and manufacturing of Intravenous products at the Thetford plant.
Essential Duties and Responsibilities
Lead validation activities on specific projects including defining the validation requirements to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP
Ability to translate local, corporate and regulatory requirements into validation requirements
Liaise with project team members
Ability to perform Risk Assessments, such as Failure Mode Effect Analysis (FMEA) for example, to critique a process or equipment and thereby define the level and scope of validation required
Ability to write User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation and / or trial purposes
Run validation project execution DQ/IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved
Proactively coordinate validation activities and act as a central point of contact for the project team for validation to ensure the projects are delivered on schedule
Be involved in the Implementation of a risk based approach to the validation of systems including computerised systems residing in Thetford. Initial system risk assessments are to be completed to determine scope and extent of necessary validation activities as well as temporary risk mitigation controls.
Author and report validation documentation to meet regulatory and Baxter standards
Resolve both GMP and business issues and deviations
Plan and prioritise their work load to ensure that agreed deadlines are met. This includes coordinating and performing validation activities, tracking and reporting the progress of activities, anticipating and removing obstacles to progress
Support and adhere to personnel policies and procedures
Provide periodic updates to the Validation Supervisor, Process QA Manager and Quality Assurance Leaders
Adhere to the Baxter Change Control Management System for all changes to existing or implementation of new systems
Perform such other duties as the management may reasonably require from time to time
On occasions, be expected to work late and at weekends to ensure time lines are met
To work in a safe manner and in compliance with all Baxter Health, Safety & Environment mandatory policies, standards and procedures.
At least 5 years experience as a Validation Engineer
Experience within pharmaceutical or medical devices
Minimum: degree level education in Pharmacy, Chemistry, Microbiology, Engineering or similar or equivalent industry experience.
Experience in Equipment / Process systems, Cleaning Validation, HVAC & Cleanroom systems would be preferred
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.