Skills: Engineering Manager, Site Engineer
Experience: 6 + Years
Education: Bachelors/3-5 yr Degree
Employment Type: Full Time Contractor
Start Date: July 2020
Duration: Initial 6 month- 2 years
·Maintain Site Validation Master plan. Responsibilities include oversight for the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages,
·Generates the Validation schedule, drives execution of workload and monitors performance to plan and tracks status of validation activities and documentation,
·Approves validation protocols prior to execution of work,
·Plan and adhere to qualification and requalification schedules. Establish and maintain system lifecycle documentation (e.g. Validation Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final reports,
·Evaluates data from executed validation protocols,
·Generates or approves Quality Risk Assessment documents in relation to executed validation activities,
·Assesses and closes deviations related to closure of validation activities
·Actively participates in relevant change control activities and risk evaluation systems as they pertain to validation,
·Liaise with the contractor's team members to ensure that the documentation is current and in time
·Liaise with contractors and Project manager personnel responsible for documentation to ensure the required PGCS, FDA & local regulation standards are met prior to final document transfer.
·Preparation of Validation Plan, Commissioning Plan, and project procedures,
·Preparation and review of FAT, Commissioning and SAT protocols,
·Preparation and review of Qualification protocols (DQ, IQ, OQ and PQ),
·Design Review (DR) and Design Qualification (DQ) protocol preparation, execution, and follow-up,
·Review and follow-up the technical documentation from the early design phase,
·Review vendor documents to support commissioning and qualification requirements,
·Create and maintain validation registers, documents, and records,
·Ensure that the Change Control Procedure is implemented and maintained,
·Create system files that will be handed over following acceptance of the validation protocols
Education / Experience
·Bachelor's degree in science or engineering and a minimum of 5 years' validation experience in the FMCG, pharmaceutical, biopharmaceutical or medical device industry
·Hands on validation experience with manufacturing equipment including tanks, Homoginizers, Pumps, sterilizers, parts washer, HVAC, controlled environmental chambers and utilities.
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