Job DescriptionWorking within the site at Digital Manufacturing Operations team, provides key automation support for various manufacturing systems such as PLC, DCS, MES, IT, and OEM systems in Manufacturing Operations.Responsible for resolution of significant automation issues and maintenance 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.Other responsibilities may include working as a representative of a startup or existing production team providing technical / leadership assistance in fulfilling the automation requirements for the team. For various project assignments / initiatives, the automation team member is responsible for working closely with various site / central groups in maintaining manufacturing requirements. 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.Key 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
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. Responsible for providing subject matter expertise knowledge for new and existing equipment following current regulatoion change controls and qualification requirements approach. Offers expertise in the subject matter for both new and existing equipment, adhering to current regulatory change controls and qualification requirements. 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 compliance requirements to document investigations and corrective actions.
Manages shopfloor system project activities following approved business processes to deliver results that are quality engrained, right first time, on-time with schedulerequirements, reconciled tothe budget, andmeet allQuality/Safety requirements. Deliver project plans, whichhave been developed andalignedwithall key stakeholders. Lead projects by engagingteammembers,settingclearexpectations,utilizingstrongcommunicationskills andexercisingcleardecision-making. Regularly and clearly communicate project plans, risks andstrategytoall key stakeholders,customersandgovernance committees. Prepares automation cost information to support necessary project plans.
Educates teammates and colleagues on manufacturing computer systems to ensure the efficient operation of various automated processing and information technology systems. This involves sharing knowledge on engineering principles and other areas of expertise as needed, serving as a subject matter expert for shopfloor control systems, creating knowledge-based problem resolution articles to share with colleagues, coordinating applicable training events and proactively sharing knowledge and experiences.
Manages repository for production equipment/system qualified automation programs and files with associated metadata. Ensures appropriate backups are maintained for recovery purposes. Ensures accuracy of site system inventory and that inventory data is current.
Responsibilities may include providing coaching leadership to other team members while exhibiting appropriate our Company Leadership standards. May manage selected external contractors - monitoring performance and ensuring contractual obligations are met.
Role requires limited off shift/weekend support and participation in an on-call rotation.
Education:
Bachelor's degree Information Technology, Science, Engineering or related technical field.
Skills (include specific skill levels required to apply our Company Leadership Principles)Required Experience and Skills:
Minimum of 8 years' experience in IT/Automation support of manufacturing or process engineering or equivalent.
Working knowledge of the regulatory requirements for pharmaceutical applications.
Working knowledge of PLCs, HMIs, Servo-Drives and Control Systems.
Effective leadership, interpersonal and communication skills (written and oral) are required.
Experience in computer validation and systems lifecycle development methodology.
Experience authoring and reviewing standard operating procedures, on-the-job-training, and other controlled documents.
Demonstrated ability to lead key projects across multiple site disciplines.
Preferred Experience and Skills:
Highly desired are skills in packaging technology equipment, Vision Systems, barcode systems, reject/verification processes, Serialization, MES, IT, and OEM equipment.
Experience with Continuous Improvement, Lean Manufacturing, Problem Solving and Right First-Time methodologies.
Data Integrity and Cyber Security acumens are desired.
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