Manufacturing Validation Engineer/QA-Permanent- Blackpool & Leeds
Recruiter
SidTech
Listed on
25th March 2021
Location
Leeds
Type
Permanent
Start Date
2021-03-25 00:00:00
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Job Title:Manufacturing Validation EngineerLocation:Blackpool & Leeds, United Kingdom Department/Practice:Life Sciences and Healthcare Job Purpose and primary objectives: The Manufacturing Validation Engineer will play a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes. Provides support for the validation activities associated with equipment, test methods & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed. Provides support for the periodic validation reviews and administration of the site validation master plan and registry. The candidate will have interface with all disciplines of manufacturing facility. Key responsibilities (please specify if the position is an individual one or part of a team): The candidate will be responsible for the following (this covers all but not exhaustive) -Provide effective and responsive validation support to Operations to meet their area’s objectives of quality, cost and output.Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. EU MDR).Ensure validation activities completed comply with US and EU relations, GBSC procedures and EHS requirements.Remediate gaps/legacy validation issues by locating documentation, data and doing reviews of current vs contemporary standards.Support changes to various process FMEAs and Article 18.General validation tasks - Updates to SVMP, documentation changes, periodic reviews.Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)Assist in development of validation strategy and validation plan for equipment and process validations.Assist in the development of sampling plans, test plans and data analysis related to process validation.Assist in resolution of deviations/ exceptions during qualification activitiesAssist with change control activities in accordance with site procedures.Prepare periodic validation review documentation for approval by the business units.Maintain site validation registry.Attend identified training, required to fulfil the role of QA Validation EngineerSupport the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.Participate in cross-functional teams as required.Effectively translate customer requirement into logical inputs for teams based remotely, including offshore team.Be responsible for adherence to timelines in a project environment and ensure project milestones are achieved.Maintain and present self and team matrices to Client and TCS management in structured and timely manner.Report issues to the Client and TCS management to ensure appropriate closure. PRINCIPLE ACCOUNTABILITIES: Process/Quality input for validation processes and new product introduction. Adherence to site validation procedures and regulatory requirements. Adherence to company procedures as detailed in Quality Manual. Key Skills/Knowledge:3-5 years’ relevant experience in Manufacturing industry (Medical devices/Pharma manufacturing is preferred but not a mandatory requirement)Hands on experience in Validation (IQ/OQ/PQ) documentation and execution practices including the equipment life cycle and regulatory expectationsAbility to analyze Capability data using MINITABAbility to interpret Engineering drawings and specificationsFamiliarity in areas of various inspection techniquesProficient with MS Office applications such as MS Word, PowerPoint, Excel.knowledge of Quality systems (FDA/ISO), 21 CFR 820, 21 CFR 11, ISO 13485 and European regulations associated with the medical device industry is preferred (not mandatory)Candidate should possess strong communication and inter-personal skills, Pro-active approach to work, Team Player, Flexible, Highly computer literate, High attention to detail, High work standards, Planner and organizer, Active listener.Experience required:Hands on Experience (minimum 3 years)in documentation and execution ofequipmentvalidation (IQ/OQ/PQ)in a manufacturing industry.Minimum of 1 years’ experience in Process, Equipment and Test Method ValidationAbility to analyze Capability data using MINITABAbility to interpret Engineering drawings/specificationsFamiliarity in areas of various inspection techniquesExcellent interpersonal & communication skillsSpecial working conditions (travel, on call etc):The job profile will require travel and work from two different client locations - Blackpool (80& and Leeds (20%)Working in the client site during COVID will be based on client COVID guidelines.
