POMSnet MES (Manufacturing Execution Systems) Recipe creation and design
Manage and implement POMSnet system changes and POMSnet recipes to align with business objectives.
Idenitfy and drive compliance with IT, safety, regulatory, operational and organisational requirements. Responsible for ensuring that all Operations SAP & POMSnet activities are completed to support Commercial Products and New Product Introductions.
Assume some supervisory roles as MES Lead, not limited to mentoring and coaching team members. Leading projects and signatory approval on system documentation.
- Support delivery of AbbVie MES strategy to site.
- Continuously review and manage business risk associated with POMSnet system and recipes.
- Continuously review and ensure all business processes, including SOPs, required to implement and manage SAP and POMSnet system changes and POMSnet recipe changes comply with current Safety, Quality and Information Technology policies.
- Continuously review and ensure all documented policies, procedures and training plans required to implement and manage SAP and POMSnet system changes and POMSnet recipe changes comply with current Safety, Quality and Information Technology requirements.
- Ensure the timely and compliant qualification of POMSnet recipes and upgrades aligned with business objectives.
- Support SAP business system as local key user (LKU) for POMSnet and material queries.
- Communicates project status by preparing standard reports and by participating in departmental and customer project status update meetings.
- Resolves project/system/recipe issues by working with team members, project customers, and others as appropriate.
- Responsible for systems compliance with quality related SOP’s
- Promote a culture of perfect performance and right first time wthin their team
- Required to front audits by HPRA/FDA or Customers on SAP and MES.
- Participate in MES knowledge exchange with other AbbVie sites
- Participate in projects from initiation to ensure MES system or hardware requirements are understood and taken into consideration
Demonstrated working knowledge of Manufacturing Execution Systems is required for this role.
Bachelors degree plus 5 years technical experience, or Master degree plus 4 years experience. Will consider 9 years work experience in related technical roles.
Job Skills/Experience Required:
Technical/Business Knowledge -Job Skills
- A strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
- Experience in a direct supervisory is required.
- A good knowledge of the POMSnet or other MES system is required for this role.
- Experience of operating in a team environment with active participation in proactive improvement programs is required.
- The position requires a high level of both personnel and time management skills to effectively administer resources, to deliver and execute all manufacturing and MES activities in line with all quality, safety, environmental and operational requirements.
- The position requires proven problem-solving skills, and the ability to adapt to new manufacturing processes as well as accommodate all new processes within the MES system 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.
- Demonstrates the highest levels of integrity and a strong work ethic at all times.
- Orientated to deliver improved performance in line with business objectives.
- Strong communication skills both verbal and written are required for the execution of this role.
- Strong interpersonal skills are required including ability to build consensus and collaborate.
- Accountable to ensure to ensure that all MES related actions, CAPAs and projects are delivered on time, right first time as reflected by site performance targets.
- This position is responsible for ensuring continuous availability of POMSnet system to manufacturing as required by manufacturing schedule.
- Responsible to ensure that all MES related actions, CAPAs and projects are delivered on time, right first time as reflected by site performance targets.
- Demonstrates high standards team adherence to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations at all times.
- Expected to work on their own initiative in line with business objectives.
- Shows a high level of tenacity to ensure closure of issues.
- Develops and maintains close relationships with customers and stakeholders
- Provide technical leadership to functional areas and collaborates with key stakeholders on MES.
- Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
- May be required to lead cost improvement projects.
- May be required to lead the delivery of new MES initiatives.
- Lead investigations and troubleshoot issues impacting provision of POMSnet service.
- Actively identifies and agrees the decision maker in each situation and collects all information relevant to make informed decision.
- Responsible for the presentation of technical data to stakeholders to ensure prompt decisions on MES related issues.
Significant Work Activities: N/A
Job Type: Experienced