Mes Author to work for a Pharmaceutical company
The role is as follows
Mes Author role
Remote - There is a chance of 2 weeks onsite anywhere in the world (this will be fully expensed)
Outside ir35
Rate - TBC
1 stage interview process next week
Start - Late June/Early July
6 months contract
Purpose:
-To maintain the POMSnet environment; to author & maintain recipes & worksheets for
API & DP manufacturing; and also author and maintain the recipes & BOMs in SAP.
- To operate as a team member within the MES team in the implementation and
maintenance of the MES & SAP system for the API & DP buildings.
Responsibilities:
- Liaise with Manufacturing and Quality to close out MES execution exceptions.
- Troubleshoot and provide solutions for all MES & SAP problems in recipe
execution and recipe authoring.
- Liaise with quality to provide approved documentation for all MES system changes.
- Design, create, write and execute system and test documentation to a high quality standard.
- Design, create, write and/or make all required changes to MES & SAP Recipes,
worksheets, equipment and material spec's including phase transition logic to a high
quality standard.
- Design, create, write and/or make all required changes to ensure cleaning,
equipment and product procedures (CIs, CIRs, MIs, MIRs and SOPs) are aligned to MES processes and vice versa.
- Design, create, write and provide training for all other site personnel on their related MES roles.
- Participate in MES knowledge exchanges, MES Governance meetings, GMES
Technical Review Board (TRB) Meetings, and manage issues, work-around and fixes identified.
- Work closely with IT regarding upgrades, patching, hardware support, security and system access.
- Liaise with GMES on Sligo 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 & E standards, procedures and policies.
Supervision Received
- The position will report directly to the Global process owner,
- Goals are reviewed on a regular basis and formal performance reviews are carried
out once per year.
Supervision Provided
- No direct reports.
- Maintains regular contact with support functions on site.
Qualifications:
Diploma qualification in suitable science/engineering course and/or suitable experience.
Job/Technical Skills
- A minimum of 5 years' experience in Batch processing operations in an FDA/ HPRA regulated industry.
- Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.
- Experience in the operating in a highly automated environment and safe handling of
dangerous chemicals is required for this role.
- A good knowledge of IT systems/MES is required for this role.
Cognitive/Business Skills
- The position requires a high level of attention to detail and mental concentration, to ensure total compliance with procedures at all times.
- The position requires proven problem solving skills, and the ability to adapt to new manufacturing process on a regular basis.
- The position requires proven technical skills, to ensure the person can cope with the technical demands of the position at all times.
- Requires innovative thinking, where new and untested solutions are proposed,
demonstrated and implemented on a regular basis.
- Must be results driven striving to meet all targets and metric standards as set by
site/department and division leaders.
- Requires total commitment to quality and maintaining a high standard of work at all
times.
- Demonstrates the highest levels of integrity and a strong work ethic at all times.
- Strong communication skills both verbal and written are required for the execution of this role.
- Strong interpersonal skills are required.
- Understands and Supports the principles of Perfect Performance.
Ownership/Accountability
- This position is responsible for ensuring the smooth running of the MES system and
ensuring availability to manufacturing at all times.
- The position has a high level of autonomy and individuals are expected to work on
their own initiative.
- Shows a high level of tenacity to ensure closure of issues.
- This position is crucial in maintaining the compliance of validated systems ensuring
that any changes or modifications are documented and actioned.
- Demonstrates an ethos of Right First Time at all times.
- Adheres to and follows all procedures policies and guidelines ensuring compliance
with cGMP and HPRA/FDA regulations and company policies, procedures and
guidelines.