applications

Description

Our Client is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing.

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.

-As needed, assist in providing related training and support.

- 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.

-Escalate any out-of-norm matters to department management as applicable.

- Any other responsibility as set out by Supervisor/ Manager.

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 intersted in applyiong please send C.V to Teresa, cork@manpower.ie