Description
Be part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on an existing Pharmaceutical plant. You would be working in a fast paced busy environment where you will get a chance to work in a variety of pharmaceutical and medical device manufacturing sitesRole Functions
- Report to the Operations Director and/or the C&Q Manager/ Project Manager on the given project.
- Coordinate & lead cross functional project teams for the Installation, Commissioning & Qualification based on planned timelines and scope.
- Attend system walkdowns in advance of achieving Construction/FAT handover of the utility generation / equipment.
- Facilitate the completion of outstanding construction punch items through required safety procedures and permits.
- Review all the appropriate installation and vendor documentation for completeness & ensure it reflect the System's as installed conditions.
- Confirm the site installation is as per approved design specification and meet system IQ requirements.
- Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
- Generate, execute and report all system test documentation (FAT/ SAT/Commissioning Test Protocols/IQ/OQ/PQ) for the project based on available approved client templates & design documentation.
- Ensure all the safety documents, i.e. Method Statements, SPA, etc. are prepared and approved prior to the commencement of execution activities.
- Coordinate local contractor company resources for all commissioning & qualification execution activities. Approve their relevant Method Statements, SPA & Permits-to-Work.
- Ensure project change(s) are properly managed and effectively documented.
- Act as the technical liaison with System vendors for support and/or, on site attendance, as required, throughout the Commissioning & Qualification process.
- Manage the site attendance for the vendors, contractors and specialist contractors.
- Confirm all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support validation.
Role Responsibilities
- Ensure that system delivery progresses in accordance with the approved project schedule.
- Notify project management, in a timely manner, of all relevant issues which may impact on system progress.
- Ability to work in construction project environment within Ireland and EU.
- Coordinate with design and/or project teams to resolve any identified technical issues.
- Organise/attend all coordination meetings necessary to progress the job.
- Possess good communication skills.
- Ensure that all works carried out on your scope or responsibility by construction, commissioning
- and contract team members are performed in accordance with site safe working practices.
- Ensure the cohesive operation of your cross-functional team and coordinate work for effective and efficient completion.
Requirements
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum of 3-4 years' experience in commissioning and/or validation of clean and dirty utilities within Pharmaceutical industry.
- Good knowledge of the Life Cycle Management Process on the qualification of regulated systems in the Life Sciences Industry.
- Willingness to travel is essential
If you are interested in this great opportunity please apply below with an up to date CV.
Not sure yet? No CV ready? Give me a call for more info Anna Mooney .