Quality Engineer

Our client is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing and are currrently recruiting validation engine

 




Description

Our client is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world's challenging human health issues. From research to development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Their Corporation is an S&P 500 company with 6,000 employees in 47 countries worldwide.
Their Bioscience division provides high performance products and application insights that improve laboratory productivity. They have a deep understanding of its customers' research and manufacturing process needs, and offers reliable and innovative tools, technologies and services.
Currently, we are seeking for Ireland a :Validation Engineer

Job responsibilities:
Reporting to the Senior Quality Engineer, the Validation Engineer is responsible for the design and execution of validation programs and strategies to support the implementation of the Validation Master Plans.
- The execution and completion of process, systems and equipment validations and revalidations in accordance with Validation Master Plans, schedules and Company policy.
- Co-ordinate activities in all areas of validation.
- Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
- As assigned, participate in cross functional teams to establish validation strategies and objectives.
-Ensure all departments understand and comply with the requirements of cGMP as applied to the validation program.
-Provide guidance and support to all departments/staff as needed regarding related issues, ensuring compliance, and all other Quality Standards, Validation Regulations and Guidance Documents.
- Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.
-Provide related updates to department management according to the latest EU/U.S and ICH requirements.
- Ensure compliance with Software and Hardware Validation regulatory requirements, 21 CFR part 11, GAMP and other guidance documents, as appropriate to the business needs.
- Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.
- Participate in/Lead the review of validation practices; monitor trends, and initiate improvement opportunities.
Qualifications

Experience & Key Competencies:
- A qualification in appropriate Quality Assurance/Science discipline and at least 5 years relevant experience in a regulated environment
- Good regulatory knowledge
- Good verbal and written communication skills, including the ability to conduct verbal presentations.
- Demonstrated success working in a team environment.
- Ability to work under pressure to meet scheduled deadlines
- Proven technical protocol and report writing skills
- Ability to design and implement validation programs

Our Client offers an attractive international working environment, valuing your talents and training you to develop new skills. We believe in building a strong relationship with our employees. If you are interested in applying to this position please send C.V to Teresa, Cork@manpower.ie