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The CSV Engineer will work within a team that design and perform validation activities associated with new installation projects and improvements to the existing manufacturing process, at the Thetford plant. You will be responsible for authoring, executing and reporting computerised systems validation activities within the framework of cGMP and in compliance with Baxter Global QMS requirements. Within this role, the engineer will be required to manage multiple validation projects, liaising with the project team and all associated departments on site relating to the validation objects and ensuring work is completed in a timely manner.
Essential Duties and Responsibilities
Lead and execute computerised systems validation activities on site including defining the validation requirements and ensuring systems compliance to EU GMP Annex 11, 21 CFR Part 11, GAMP 5, along with the continuous regulatory expectations.
Run computerised systems validation project execution DQ/IQ/OQ/PQ in conjunction with relevant stakeholders, ensuring timelines are met and deliverables achieved.
Proactively coordinate computerised systems validation activities and act as a central point of contact for the site for computerised systems validation to ensure the projects are delivered on schedule.
Ability to translate local, corporate and regulatory computerised systems requirements into validation requirements.
Ability to write User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for computerised systems validation or trial purposes.
Ability to perform risk management on computerised systems, assess the impact on compliance with EU GMP Annex 11, 21 CFR Part 11, GAMP 5,
and translate the results into action and implementation plans to then execute.
Have expertise in the specific area of computerised systems validation. Also to have a breadth of validation knowledge to allow adaptability to the different types of validation to be conducted and to understand the interaction between the different areas of process and validation that are impacted by the computerised systems.
Liaise with project team members.
Identify, develop and maintain stakeholder relationships.
Represent validation from a Computer Systems/Software Validation perspective at both internal and external audits.
Support and adhere to personnel policies and procedures.
Author and report computerised systems 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 co-ordinating and performing computerised systems validation activities, tracking and reporting the progress of activities, anticipating and removing obstacles to progress,
Provide periodic updates to the Computerised System Validation Manager, QA Manager and other relevant personnel.
Train staff in computerised systems validation procedures and principles during execution activities.
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.
Internal Contacts - On a daily basis the job holder will have contact with production managers, supervisors, engineers and production staff.
External Contacts – Liaise with suppliers and vendors inputting to the validation of projects being handled.
Minimum degree level education in Pharmacy, Chemistry, Microbiology, Engineering or similar or equivalent industry experience.
Specific training and education in computerised systems validation and / or their implementation in the pharmaceutical industry desired but not essential
Ability to build and maintain excellent working relationships.
Excellent communication skills.
Ability to work in a multi-disciplinary team and at all levels.
Have a detailed understanding of GMP, quality assurance and documentation systems in a pharmaceutical environment.
Have expertise in computerised systems validation and be able to interact with and assist in assessing the impact of the computerised systems on key validation areas required by the team including but not limited to EBR, SCADA, MES.
Be proactive in identifying problems and proposing solutions.
Be able to write and execute computerised systems validation plans, protocols and reports.
Be capable of assessing available data and taking a decision on whether or not sufficient information is present to support the validation conclusions.
Be capable of effectively communicating, both written and oral, to all levels of staff on the site and visitors in a tactful, diplomatic and knowledgeable manner. This includes ensuring that the production and project managers are kept informed of progress to minimise the impact on production and projects.
Be able to prioritise their own and others workload and work under pressure to meet deadlines.
Be able to lead the computerised systems validation on projects and supervise the activities of operators working on the project, inputting to the validation. This will involve time and workload planning, but not necessarily direct line management responsibility.
Be able resolve both GMP issues and deviations and perform investigations as and when required.
Be computer literate with experience of Microsoft packages.
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.