Salary: £Competitive + Benefits
Hours: Full time
Job Type: 6 Month Contract
This role is for a Validation Engineer within a team 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.
The Validation Engineer function will work within one of six areas in a stream approach:
- Equipment / Process systems
- Cleaning Validation
- HVAC & Cleanroom systems
The Validation Stream Leads are expected to be the primary contact and validation subject matter experts (SME) for their particular field. They are also the owners of the validated state pertaining to their streams.
It is, however, also expected that the successful candidate will be able to interact and cover, at times, within streams other than their own. Therefore, a wide range of experience is being looked for in a suitable candidate.
As part of the above, this role is responsible for authoring, executing and reporting validation activities within the framework of cGMP – Annex 11 & 15 and in compliance with Baxter Global QMS requirements.
Within this role, the engineer will be required to manage multiple validation objects, liaising with the project team and all associated departments on site relating to the validation objects and work is completed in a timely manner.
The primary skill of the role requires the applicant to have a good working knowledge of Validation requirements for Equipment / Facilities / Utilities including associated control systems. In addition a working knowledge in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and associated computerised system validation within the pharmaceutical environment.
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
Minimum 5 years in validation, minimum 5 years
Field of expertise: Equipment / Facilities / Utilities