Validation Engineer

Are you a Validation Engineer interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

A Fantastic new role has just opened up at one of our leading British based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities:

• You will 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.
• As a Validation Engineer onsite you will be developed into the primary contact and validation subject matter expert, responsible for authoring, executing and reporting validation activities within the framework. You will manage multiple validation projects, liaising with the project team and various departments relating to the validation ensuring work is completed in a timely manner.
• You will be trained on the of Validation requirements for Equipment / Facilities / Utilities including associated control systems. In addition, you will gain the working knowledge in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and associated computerised system validation within the pharmaceutical environment.
• 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 the clients 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
• Provide periodic updates to the Validation Supervisor, Process QA Manager and Quality Assurance Leaders
• Adhere to the clients Change Control Management System for all changes to existing

Requirements:

• 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, QA, QC or Cleanroom systems would be preferred

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-SH1