Overview:
This is an exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The team is responsible for a diverse range of activities including analytical development, product development, verification and validation and on-market support of reagent kits.

Responsibilities:

• Perform and plan design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products.
• Develop, test and refine prototype products.
• Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
• Plan day to day activities, ensure sufficient supplies of materials to carry out tasks etc and organise all proficiency testing within the laboratory.
• Carry out work in accordance with defined processes and laboratory procedures.
• Ensure that all work is compliant within the existing quality processes and GLP
• Perform investigative work as required by the organization to support reagent kits
• Maintain detailed experimental records.
• Create and revise laboratory SOPs as required
• Travel to other sites/ countries for the transfer of knowledge etc.

In return you will receive:

• Learning and development opportunities to further your career.
• Competitive salary
• Private health insurance
• Life and long term disability insurance
• Company pension contributions
• EAP program

Qualifications:

• At least 2 years proven experience of working in a laboratory with analytical equipment such as HPLC or UPLC. Practical experience of LC/MS/MS would be an advantage.
• Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
• 3rd level Degree in Science or related discipline
• Good verbal and written communication skills
• Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
• Familiarity with basic laboratory procedures including gravimetric and volumetric preparations.
• Microsoft excel training or substantial experience utilizing excel is required. Ability to use Macros is desirable.

EXPERIENCE DESIRED:

• 3rd level Degree in Science or related discipline
• At least 2 years product development and design experience- Experience working in an R&D environment (pharmaceutical or medical device) or a Clinical laboratory would be advantageous.
• Understanding of the requirements of quality management systems- ISO13485 & 21CFR820
• Knowledge of Non Conformance, Change Control and CAPA systems
• Good verbal and written communication skills
• Travel to other sites/ countries for the transfer of knowledge etc
  Company Description:
  Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science.
  Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time

• Perform and plan design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products.
• Develop, test and refine prototype products.
• Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
• Plan day to day activities, ensure sufficient supplies of materials to carry out tasks etc and organise all proficiency testing within the laboratory.
• Carry out work in accordance with defined processes and laboratory procedures.
• Ensure that all work is compliant within the existing quality processes and GLP
• Perform investigative work as required by the organization to support reagent kits
• Maintain detailed experimental records.
• Create and revise laboratory SOPs as required
• Travel to other sites/ countries for the transfer of knowledge etc