Crest Solutions are seeking a Serialisation Engineer to join our team and work on our customer site in North Dublin.
What We Do:
Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.
Responsibilities and Tasks:
Installation, commissioning, validation & servicing of the vision, software, electrical, and mechanical based elements of serialisation solution at customer’s site
Configure, integrate and validate print and vision equipment
Ensure all hardware and application issues identified in production are risk assessed to mitigate any batch impact and all associated Deviations, Risk Assessments & CAPA’s s are addressed effectively
Support IQ/OQ/PQ validation activities for introduction of new serialised and aggregated automated packaging lines equipment.
Support the maintenance and operations of the serialised and aggregated equipment onsite for the introduction of new markets and products as required.
Support the operation of the company's Serialisation Site system and the software/hardware systems integral to the system, such as HMIs, Scanners, and system software GTS, MTS, HTS, STS etc.
To monitor and control the acquisition of new computerised equipment/ software and ensure that we are standardising on equipment type as much as possible.
To study, evaluate and document existing processes and highlight areas on systems where errors or potential errors may occur.
To modify control strategies and redesign serialisation processes where appropriate to suit current and future requirements.
To liaise effectively with the Business Units, QA and Compliance in carrying out the above work so that the requirements of each in terms of quality, cost and output are met.
To follow up on qualification deviations.
To provide software validation, service to other Departments for the Antares system when required.
Liaise with Project Engineers to ensure any new or changes are completed within compliance
Maintain all Antares drawings, manuals, records and documentation in an orderly and accessible fashion and in accordance with the Engineering Documentation Procedures.
To ensure that all work is to the highest standards and in compliance with all requirements i.e. FDA, GMP, GAMP, etc.
To communicate effectively within the Department and particularly with the customer.
Ensure that change control procedures are strictly adhered to, while advising the customer on their duties in this respect.
Ensure that all procedures described in the Department SOP's, WI's and Guidelines are strictly adhered to.
Pay due care and attention to Health and Safety and Environmental matters.
To participate in problem solving exercises.
Assist in Market onboarding compliance readiness
Investigate integration issues with all Antares interfaced systems, ( Level 1, 2, 3 & 4)
Drive continuous performance improvements to serialisation solution through application patch management, disaster recovery implementation and business continuity planning
Support serialisation solution upgrade from design phase through both hardware qualification and software CSV lifecycle
Why Join Crest Solutions?
At Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Crest Solutions benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:
Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme.
A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment.
A structured approach to professional development opportunities with an educational assistance program.