Description
Equipment Validation Engineer with expertise in commissioning and qualifying manufacturing and packaging equipment. Working for a global pharmaceutical organisation on a long contract basis. Based at their European manufacturing base in Ireland, C&Q Engineers will join the project from URS stage through to OQ.Position Summary:
Validation / C&Q Engineers will be responsible for leading the commissioning and qualification of manufacturing equipment. Taking ownership for the creation of high quality technical and life cycle documentation for equipment (URS through to OQ, including related procedures).
Main duties and responsibilities:
* Lead the generation and execution of lifecycle documentation for equipment under their ownership (URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, procedures etc)
* Testing and qualification of Mfg Equipment/Packaging systems and processes
* Early management of the operational, environmental, safety and technical aspects of the equipment/packaging processes to ensure smooth product commercialisation.
* Leading investigations and implementing corrective and preventative actions for their respective areas of responsibility.
* Assist in necessary training of the personnel.
* Follows cGMP guidelines, safety procedures, and SOPs at all times.
Key Skills and Competencies required:
* Technical writing - Ability to write high quality technical documentation, protocols and reports
* Experience working is a highly regulated GMP environment is very important.
* Knowledge of Aseptic Manufacturing process is desirable but not essential.
* Experience in automated manufacturing equipment.
* Good organisational/administrative skills
* Competent design knowledge
* Effective communication and presentation skills in one-on-one and group situations.
* High proficiency in using Microsoft Word, Excel, PowerPoint and MS Project
* Self-directed and self-motivated.
Education and Experience:
* Bachelor’s degree from an accredited college or university in a Technical discipline.
* Experience with working in a regulated environment preferably within a Pharma/Biotech facility.
This is a long opportunity working on an exciting, bespoke product working on the early stages of a complete tech transfer project.