Section 1: job position summary
The Johnson & Johnson family of companies is globally active in Pharmaceuticals, Medical Devices and Consumer Health Care. We employ over 135,000 professionals in 60 countries, and they all have the same credo ‘Caring for the world, one person at a time’. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of billions of people.
J&J Vision Care Ireland is a medical device company which develops and manufactures contact lens. We are now embarking on introducing a new manufacturing platform for intra-ocular lenses and glaucoma implants. At the Controlled Environments Product Site in Limerick, dedicated and multi-scaled people are working in a high-performance culture in which innovation and a 'can do' state of mind are the central points. To strengthen our team, we are continuously looking for enthusiastic, dedicated people who have the ambition to develop themselves and can be of value to the company.
What’s In It For You?
As an employee we consider you as our most valuable asset, and we take your career seriously. You’ll be part of a distributed team in an innovative and international environment with room for your personal and professional development. Through on the job training, various projects, and programs, we ensure your personal growth by focusing on your talent. Our benefits assure our care for you and your family now and in the future.
The Product assembler will work as part of the team to support the introduction and scale up of production of a new medical device (intraocular lens) at the site in Limerick. The role will support the creation of and adherence to all relevant procedures and GMP requirements, and demonstrate competence and ability to produce the highest quality medical device.
Section 2: duties & responsibilities
- Responsibility for the general assembly & manufacture of Intraocular Lenses in accordance with the production planning schedule, applicable work instructions and GMP requirements. − Working in a cleanroom and packaging environments and ensuring own areas of work are kept to a high GMP standard. No housekeeping issues on own areas of work.
- Use of tooling, such as tweezers, for the movement and manipulation of product to complete assembly of Intraocular Lens medical devices accurately.
- Evaluate product at all stages of processing for damage and irregularities that affect safety, quality of device function.
- Perform Line Clearance and reconciliation at the start of shift and when completing a change of work order as per relevant procedures. Ensure the vital tools, materials and documentation are available and in good order for the required production run schedule.
- Performs maintenance tasks such as storage, management and cleaning of tools, working environment and equipment and raise malfunctions in a timely manner.
- Utilise good documentation practices when completing manual and electronic records and ensure data integrity requirements are followed when recording relevant production data, rejects etc.
- Contribute to any improvement initiatives in the production area and have good verbal and written communication skills.
- Reporting of any non-conformance or quality issues promptly.
- Conduct training for new and existing staff. − All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform. − Maintain a Credo & Behavioral Standards based culture within the group
Qualifications - External
SECTION 3: EXPERIENCE & EDUCATION
- Leaving cert or equivalent
- Prior experience working in a highly regulated medical device GMP environment.
Section 4: required knowledge, skills, abilities, certifications/licenses and affiliations
- Prior experience using SAP or equivalent systems.
- Prior knowledge of FDA or similar regulatory requirements.
- A demonstrated ability to work independently and in team-oriented environments, of change, risk mitigation, and flexibility will be needed.
Section 5: location & travel requirements