Job Description

The person will provide expertise with the MES system to enhance a digital, integrated shop floor. The person will also help establish standards and templates for eBRs as required.

Responsibilities include:

• Production:
  

• Responsible for ensuring MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements.

• Managing small projects related to MES and ensuring that the appropriate controls, approvals, and validation requirements are implemented

• Training /Deviations /Compliance:

• Ensuring that Process, Equipment and Automation documentation is compliant and inspection ready.

• Participating in inspections conducted by external regulators

• Partnering with direct and indirect management chain to ensure the following:

• Assisting with Department Training Plan and supporting execution.

• Ensuring Inspection Readiness of assigned areas

• Assisting completion of investigations and deviations.

• Continuous Improvement:

• Working collaboratively with inter-department and cross-functional teams to support necessary changes in a timely and productive manner

• Identifying opportunities to improve manufacturing processes and practices

• Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR\'s, OJTs) is accurate

• Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process

• Partnering with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM in their area of responsibility.

• Ensuring that internal customers and suppliers are aligned with the solutions and services of the department.
  

• Bachelor\xe2\x80\x99s degree in Engineering, Science and 0 to 2 years relevant work experience or 5 years of relevant work experience

• Experience with at least one computerized system (Werum PAS-X, DeltaV, PI, etc.)

• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).

• Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.