Sr. Spclst , Manufacturing Automation (Rota POD IPT Lead)

Job Description

Senior Specialist, Manufacturing Automation (Rota POD IPT Lead):

Responsible for working both as an integrated process team lead (IPT) and as a technical subject matter expert that will enable Our Company to deploy and operate a one-of-a-kind facility with a full end to end process consistent with global business processes, common global information, and IT supporting projects / application / technology suite.  This position requires knowledge and experience in own discipline while still acquiring higher-level knowledge and skills.  The position will build knowledge of the company, processes, clients/customers and will solve a range of problems while providing possible solutions.  This position may often work autonomously with a moderate level of guidance and direction.  In group work, applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.  The lead will provide key automation support for various utilities/manufacturing/packaging systems such as PLC, DCS, MES, IT, and OEM systems in Manufacturing Operations as well as IT, supply chain, MES, and PI/RtReport systems.  The individual will work across all phases of the building (qualification and run/operate) and report progress to goals/changes, identify key risks and mitigation strategies, provide direct support for other process teams, support deviation management, and complete other duties as needed or assigned.  Responsible for resolution of significant automation issues and maintainance of automation systems in compliance with cGMPs, SLC, safety, and environmental regulations. Provides guidance on process control, data collection techniques, and failure mode and effects analysis.  Develops strategies to optimize and ensure quality and stability of automation systems though future expansion, replacement, or upgrade.  Supports preparation of digital/automation cost information to support necessary plans.  Lead automation related investigations into Atypical Production Reports (APRs) and implement the corrective actions.  Group supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automation technologies and make a positive impact. Responsibilities include providing automation leadership/support on limited shifts/weekend in support of Manufacturing Operations.  Responsibilities may include coaching responsibilities and management of contract resources.

Primary Activities:

• Leads and provide key shopfloor support for various manufacturing systems such as PLC, DCS, MES, IT, Inspection, Serialization and OEM systems within Manufacturing Operations.  Serves as interface between operations and other digital support organizations to resolve issues impacting shopfloor operations. Collaborates with Operations, Quality, Maintenance and other Technical groups to resolve complex problems and provide innovative solutions. Participates in daily tier meetings and governance processes as necessary

• Leads qualification activities for packaging suite and works with stake holders to ensure timelines are met and risk are escalated.

• Provides direct support of validation activities and other associated Quality functions required.  Develops and maintains technical documentation as necessary.  Participates in audit and training programs in area of responsibility.

• Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade. Identifies and implements process/equipment improvements and manufacturing efficiencies. Provides guidance on process control, data collection techniques, and failure mode and effects analysis.  Prepares automation cost information to support necessary plans. 

• Understands and supports all GMPs, safety, and environmental regulations.  Maintains shopfloor systems in compliance with SLC, cGMPs, safety, and environmental regulations.  Provides leadership in the analysis of system data integrity requirements and system security.  Periodically authors and reviews system documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety. Participates in audits and training programs as SME in appropriate areas of knowledge and responsibility.

• Responsible for recognizing and addressing irregularities in shopfloor systems and automated equipment. This involves troubleshooting issues, devising solutions, and implementing measures to rectify or prevent these anomalies.  In atypical shopfloor system incidents, leads/supports investigations to determine root cause.  Formulates and supports corrective measures to prevent recurrence. Addresses complianc