Project Engineer
- Ireland, Midlands (Ireland)
- Contract
- CAPEX Projects
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for Project Engineer to join their state of the art pharmaceutical facility.
Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports.
Responsibilities
- Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic
- Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
- Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
- Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
- Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified.
- Liaise with Global MES on required system improvements.
- Provide support to other MES system users as required to ensure business continuity.
- Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
- Keep other recipe authors up to date on MES changes
- Documentation of all activities in line with cGMP requirements.
- Cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
- Adheres to and supports all EHS standards, procedures and policies.
Requirements
- Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
- A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.
- Be proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
- Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
- A good knowledge of IT systems is required for this role.
- SAP knowledge/experience in MM, PP and IM modules.
- Proven attention to detail and mental concentration, to always ensure total compliance with procedures.
If this role is of interest to you, please apply now!
#LI-JS4
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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