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Validation Engineer

Job title: Validation Engineer
Contract Type: Contract
Location: Portsmouth, England
Industry:
Salary: £0 - £55 per week
Reference: BH-91216
Contact Name: Daniel Leach
Phone Number: 01
Job Published: 3 days ago

Job Description




Project.                        Sterile PPC Vial filling Line

for:                                Lead validation Engineer

 


 

Scope of Work & Deliverables

Request for delivery and execution of the following project activities.
PPC Filling Project

 

 

The Project role involves working under the Project Manger as a Validation Project Lead.

 Involvement in supplier led documentation review and control, and commissioning and validation activities.

Project deliverables; Overall organisational responsible for all Project Quality documentation. The assessment of required Quality plan for new Bosch Filling Line and Telstar Freeze drying system, inclusive of Facility and data control. ( PMS , Eurotherm etc).

 

Project activities, deliverables and scope include but are not necessarily limited to:

 

 


    1. Report to the Technical Lead and Senior PM on the progress of the project Validation Plan.

    1. Creation and control planning of documents to priority of project goals.

    1. Overall control of Quality plan for all elements of the project.

    1. Active involvement in the execution of test documents.

    1. Witness and review for testing plans for all Equipment, (NOTE: Must not assume responsibility for design).

    1. Make direction for PPC  Project Manager and Project validation Engineer during IQ/OQ, and be actively involved in the  process

    1. Assemble any documents issued by the Vendor, and collate ready for handover to Operations.




    1. Represent the project Team at meetings with the Main Contractor’s Commissioning Managers

    1. Work with PBL’s on other elements of the Project for information system integration such as connection to Eurotherm system i.e. SCADA

    1. Overall management of CSV Plan in alliance with the Project CSV Engineer (plan and assess required activities thereof.).

    1. Creation of associated wrap around documents and assessments required for all aspects of CSV project requirements for a GMP project



 

 

Project Reporting


    • An equipment validation engineer for Filling Line and a CSV Engineer will report to the Validation Lead and the project manager.



 


    • Liaise with all members of PPC filling project Team for technical



 

 


    •  




 


 


Project.                        PPC filling Line

for:                                Validation


 

 

Key Skills

 

Fully conversant with;


    • GAMP4/5 life-cycle 

    • FDA 21 CFR Part 11 

    • EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines “Annex 11 (Computerised Systems)” 

    • ‘Risk-Based’ approach to validation 



 

 

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