Ref No: AM17654
County Dublin, Republic of Ireland
Process Validation Engineer - South Dublin.
In this capacity you will ensure that the design, installation and operation of plant and equipment have been validated in compliance with current regulatory requirements.
Main responsibilities will include:
Support Site and Corporate Change Control procedures
Use of Company Validation Toolkits
Author User Requirements Specification and System Requirements Specification, leveraging the inputs from Quality, Operational, Automation and Process Development
Review and sign-off of vendor-provided System Design Specification, Functional Design Specification and Design Reviews as a Validation resource, as part of the assigned project team
Validation resource, across a variety of processes, as part of the overall Value Stream.
Liaise as Validation representative on ACR process
Maintain site Validation Master Plan in relation to projects of a variety of scopes and size across multiple value streams for a variety of product configurations, including, but not limited to:
Major Capex, Site-Critical projects of new equipment for full project timeline
Continuous Improvement-driven upgrades to existing equipment
Relocation of production lines in the General Manufacturing Area
Quality-Driven in-line vision and inspection systems
Crossline Product Validations to ensure redundancy
Ancillary Equipment Validation
Maintain Requirements Trace Matrices to ensure all user requirements specific to the projects are delivered prior to introduction
Maintain CSV database
Maintain CFR Part 11 Assessments
Assist with Process Development in:
Establishment of KPIV/KPOV/KPI/KPO/CTQs matrix
Conducting DOE and MSA
Define validation sampling and inspection plans based on Risk Assessment in relation to pFMEA and product specifications
Statistical analysis for normality, PPK, ANOVA and T-Testing
Ensure all product at risk as a result of validation changes are contained prior to ACR closure through QN product hold process
Draft and execute FAT, SAT, MSA, IQ, PD, OQ and PQ on new/revised processes
Develop and execute software test cases to support changes as necessary
Root Cause Analysis and containment of deviating product during Validations
Create and control pFMEA, Control Plans and Risk Management documentation through product life cycle
Publish site specific progress reports to all levels of the business as required
Update documentation via documentation control system, SAP, for documents such as:
Product and Component Specifications
SOPs - Line Clearance, IPCs, and Operations
Link with Post-Validation activities including closure of Change Control and Microbiological testing
Participate in regulatory audits and inspections
Integrate with cross-functional teams from Quality, Process Development, Operations, Engineering, Supply Chain, H&S, R&D and support Validation requirements on wide range of projects
Support further development of Validation team, Validation efficiencies and capabilities
Interested applicants should have:
Third level qualification in relevant area of Engineering / Quality or Manufacturing.
Aptitude to understand and apply Medical Device Regulations.
At least 2 years' experience working in Pharmaceutical / Diagnostics / Medical Device manufacture, or equivalent.
A minimum of 2 years' process validation experience
Ability to draft and approve protocols and reports as required.
Process development experience (DOE’s etc)
Risk Analysis/Risk Management, FMEA’s, etc
Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt)
Software validation experience is desirable particularly in a 21 CFR Part 11 environment.