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  • 6 days ago

jobs description

QA Validation Process Engineer

QA Validation Engineer

Based within the QA department the QA Validation Engineer will be responsible for providing the company with technical and quality resources to manage the quality deliverables on projects, coordinate the necessary activities for ensuring the timely closure of internal/external quality issues and ensuring an effective quality system.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing... field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia and Israel. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

Department Description

As QA Validation Engineer you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.

In this role you’ll be reporting to the QA Validation Lead.

Your Responsibilities
• Quality review and approval of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
• Work in conjunction with Engineering Departments to co-develop design verification & validation protocols for new products and for changes on existing products, review and approve protocols/studies, and perform general oversight responsibilities for the validation process (both equipment and processes).
• Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.
• Active member of the QA review board to provide overall quality direction and oversight for key functional areas (i.e. PEV, QC, Supply Chain, Engineering, CSV), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations
• Act as a Quality point of contact and support decision making during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet client and regulatory expectations.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
• Perform all activities in compliance with client safety standards and SOPs
• Assist in implementation of global standards and procedures into the site Quality Systems.
• Provide regular reporting for KPIs, metrics, dashboards and other efforts
• Participate in other projects/duites as assigned.

Your Profile: The ideal candidate for this position, will have the following:

Education
• Bachelor’s degree in an Engineering or Scientific related discipline.

Knowledge/Experience

Required:
• Robust experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing.
• Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous);
• Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)
• Understanding of principles of Validation and New Product Introduction and be familiar with Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices

Personal skills

Preferred:
• Ability to operate across functional boundaries, both internal and external
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on + 353 86 126 3871 or send your CV to [email protected]
Dundalk County Louth Ireland

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