Facilitate and participate in process mapping of business processes
Creating and maintaining AMPS master data within the system
Creation and modifications to AMPS training curricula from Core to Site specific training
Direct the coordination of standard work practices assuring the alignment of supporting systems and reports
Manage system changes through document review and change control review and approval within QTS
Collaborate with SME’s, coordinate requirements gathering, and facilitate system training for system changes.
Reassess the business processes at intervals to eliminate non-value-added activities and drive continuous improvement.
Participate in cross functional teams to support, enhance, and upgrade AMPS:
Lead project plan
Master data cleanup
Leverages key stakeholders across DP, API, Quality, SCO, BT, and PGE to achieve goals
Supports strategy through participate in key systems projects (LSS, MAP, Gelfoam, COVID)
Subject Matter Expert (SME) to one or more Business Systems or Processes, which includes the following:
Initial point of contact for users with system functionality and associated business process questions
Communicates to user base system upgrades, enhancements, and outages
Updates SOPs pertaining to AMPS
Provides local training as appropriate, as well as, maintain Site AMPS training curricula
Participates in cross-functional teams in defining and implementing components of an EBR strategy
Reassess and participate in an agile change environment to enhance the process at intervals to eliminate non-value-added activities and drive continous improvement including supporting projects and deployments.
Assist in the work required to train, execute, track and reporting duties for other colleagues of the Business Systems Support team.
Operates within established HR policies and basic colleague relations guidelines.
Provide solutions to a variety of problems of moderate scope and complexity.
Contributes to the completion of specific programs and projects.
Ensures that project completion on schedule following targeted schedules.
Represents the organization in providing solutions to difficult issues associated with specific problems.
Interacts with middle manager internal and external personnel on matters requiring coordination between areas.
Works collaboratively with both internal site and above site colleagues to gain agreement on solutions and course of action
Some contact with outside organizations and customers.
Bachelor's Degree – CIS, ISM, Business, Engineering or Related Field.
System based experience
Minimum 1-5 years of experience
Experience with troubleshooting AMPS production issues in a timely manner
Strong organizational skills in a multi-disciplinary environment.
Knowledge of basic leadership principles; Focus is on leading/overseeing defined processes.
Refers to policies and practices for guidance.
Ability to follow established procedures.
Recommends actions and corrections when not aligned with objectives.
Motivates others, generating commitment and a shared sense of purpose
Applies extensive technical and industry-specific expertise and has full knowledge of the requirements of other related disciplines.
Demonstrated skills in leading, planning, and developing successful business processes/business units.
Familiar with MES, SCADA, DCS, PLC, and other production control systems associated with the manufacturing process.
Previous experience with AMPS in the following modules:
Data Manager (Equipment Administration)
Experience with the following:
Business process mapping
System architecture mapping
Technical experience (AMPS, Rockwell)
Data management and control.
Previous experience in Drug Product Manufacturing, Biologic Drug Substance Manufacturing, and/or Chemical Processing
Proficiency in Microsoft office suite products (Word, Excel, Power point)
Knowledge of Pharmaceutical business processes (Weigh and Dispense, Manufacturing, Filling, Packaging)