Job Information
embecta Process Validation Engineer in Dun Laoghaire, Ireland
embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn , Facebook , Instagram and Twitter .
This role ensures that the design, installation and operation of the plant and equipment has been validated in compliance with regulatory requirements,
Responsibilities
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.
Continuous Improvement-driven upgrades to existing equipment
Relocation of production lines in the General Manufacturing Area
Quality-Driven in-line vision and inspection systems
Cross-Line 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.
Link with post-validation activities including closure of Change Control and Microbiological testing.
Participate in regulatory audits and inspections.
Education & Experience
Third level qualification in relevant area of Engineering / Quality or Manufacturing.
Aptitude to understand and apply Medical Device Regulations.
2+ years working in Pharmaceutical / Diagnostics / Medical Device manufacture, or equivalent.
A minimum of 2 years process validation experience
Draft and approve protocols and reports as required.
Execution of IQ, Process Development, OQ and PQ on new/revised processes 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.
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