Quality Engineer

Job description / Role

Responsibilities:
• Responsible for preparing, executing, and/or reviewing validation documents.
• Working knowledge of the principles of validation, as associated with performance of work for the Life Sciences industries.
• Demonstrate an understanding of current GMP.
• Individuals must represent the company at partner sites and interact confidently with partners, contractors, management, and peers.
• Protocol development skills will include ability to develop or review Installation, Operational and simple Performance qualification documents on subjects like; laboratory equipment, facilities utilities, process equipment, packaging equipment/configurations, cleaning, computers, HVAC, or controls.
• Prior to new product launches; coordinate simulated distribution and thermal profile testing of packaging materials and packaged components to ensure product quality during transit from partner sites and through the supply chain.
• Review and approve artwork/labeling development and changes, if needed.
• Ensure packaging components are designed for the specific intended use with drug product, and secondary packaging components.

Benefits:
• Attractive Salary Package

Requirements

Education / Certifications:
• Bachelor’s degree in engineering
• Certified Packaging Engineer is desirable, but not required

Experience:
• 5-10 years of experience and broad career progression within the pharmaceutical drug development and/or sterile drug manufacturing industries strongly preferred, with specific experience in quality, regulatory and/or manufacturing
• Proficient in pharmaceutical and combination product container closure systems including the following: vial/stopper/seal, SVP and LVP pre-filled bags, pre-filled syringes, ampoules, and solid oral dosage forms
• Technical packaging technology knowledge relating to materials, equipment, design, and material specification writing
• Excellent technical writing and verbal communication skills. Experience negotiating is a plus
• In depth knowledge of current GMP and GLP as well as FDA trends and guidelines
• Willing to travel domestically or internationally as needed up to 10%

About the Company

Dragon Recruiting is a leading international staffing and recruitment company, head-quartered in London, with further offices all over the globe. Our clients range from numerous well known UK and international businesses. We also represent a wide range of less well known clients - helping them to find staff for their businesses around the world.

As an international recruitment agency, our clients benefit from a vast network of human resource specialists who attract, cultivate and connect organisations to talent in both global and local markets. Our unrivalled

scope of services and global reach allow us to share candidates and roles across borders. With greater coverage and tools, we can ensure our clients and candidates all get the best outcome for their recruitment needs.

With experience of over 3 decades we are recruiting more than 10,000 workers annually to and from the UK, USA and the Middle East and several other Asian countries. We specialize in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world.