MES Project Manager
- West
- Contract
- Life Sciences
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a MES Project Manager to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow.
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 Abbvie Global MES on Westport 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.
- 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.
#LI-EB1
I have always received a highly professional & personable service from the team at Quanta. 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
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
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’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 Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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