Position Title: Combination Products (CP) Senior Scientist Microbiology
Report to: Senior Manager, Quality Laboratories
Johnson & Johnson Vision Care Ireland is located in Limerick and produces the Acuvue range of contact lenses which is the leading contact lens product in the world. Our Limerick site uses the most advanced technology in the industry and we now employ over 1000 people directly. Using our highly automated production process, we produce daily disposable contact lenses while utilizing state of the art technologies such as injection moulding, robotics, vision systems and sterilisation systems.
Johnson & Johnson Vision Care Ireland was established in 1995 in the National Technology Park close to the University of Limerick. The facility was originally fitted with six advanced production lines to manufacture one daily disposable contact lens for the European and Japanese markets. Since then we have expanded a number of times and now have over 31 production lines manufacturing one-day, fortnightly, monthly and colour contact lenses which are shipped worldwide.
Each year, we have increased output because of the increase demand for our Acuvue lenses throughout the world Continued expansion of our product lines and extensive engineering and retrofit projects ensure that this growth is sustained well into the future.
Supports the Laboratory lead in the planning and directing of overall microbiology activities. Assures that non-conformance investigations, laboratory investigations and quality systems are compliant with Good Manufacturing Practices and Good Laboratory Practices as established in the code of local government regulations and company procedures.
Main areas of responsibility:
· Supports the Laboratory lead in the planning of the microbiology program and coordinates sampling activity in support of routine testing etc.
· Coordinates and prioritizes laboratory activity in support of routine testing, product release, product shelf-life, process non-conformances, complaint investigations, regulatory submissions, etc.
· Acts as a technical expert on microbiology for relevant technical issues, methods, protocols, procedures, cross functional meetings, etc.
· Coordinates equipment qualification, equipment calibration and preventative maintenance tasks as appropriate.
· Completes Test Method validation/ verification/ transfer protocols and reports as appropriate.
· Is a point of contact for team members for investigations/ lab errors and documentation queries.
· Tracks, reports, & improves key quality indicators for laboratory compliance and efficiency.
· Performs other related duties as assigned by management.
Education & Experience
· Minimum of a Bachelor’s Degree in a related Science/Management field.
· 3+ years of industry experience working in Quality Assurance and/or Research and Development.
· Understanding of basic Microbiology / Sterilization / Stability / Quality System principles and practices.
· Technical depth to make solid business decisions.
· Ability to interpret GMPs, regulations, corporate and company policy.
· Thorough knowledge of FDA and International Regulatory requirements.
· Excellent organizational, interpersonal, written and oral communication skills required.
· Proven leadership and problem-solving skills.
· Ability to work on own initiative and flexible work ethic.
· Innovative development techniques and strategic thinking abilities.
· Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross-functional activities and issues.
Johnson & Johnson Vision Care (Ireland) Limited (8182)