Senior IT Manager-Manufacturing Systems-Pharma Experience a MUST

THIS ROLE CAN SIT IN PISCATAWAY, NJ OR BROOKHAVEN, NY.The Senior Manager of Manufacturing systems will drive technology solutions for digitization at the manufacturing shop-floor level. She must be familiar with ISA-95 standards and activities ranging from plant scheduling and operations to manufacturing operations management, and monitoring, supervisory control, and automated control of the production process, including Manufacturing Control Systems (PLC/HMI), Digital Factory/Manufacturing Execution Systems, and Enterprise Track and Trace/Serialization Systems.Core activities include collaborating with business partners to understand their current and future state strategy, needs and requirements from a global perspective; to identify and prioritize areas for opportunity; gather and refine requirements, determine options for solution design, deliver enhancements, support integrations, and contribute to technology-driven projects and initiatives. Once solution delivery projects are underway, manage the governance, provide project oversight, and drive the schedule to ensure adherence to the documented requirements of assigned IT Systems. This includes the full system lifecycle management process (system development, system maintenance & operation, compliance with regulatory requirements, incident & change management & retirement of systems). Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, Financial, Data Protection, etc.).This includes the full systems life cycle management including system development, system maintenance & operation, compliance to regulatory requirements, incident & change management & retirement of systems

• New systems selection and implementation:
• Interface with Manufacturing, Supply Chain/Warehousing, Facilities, Validation, Engineering, QA and QC to collect and document user stories / requirements for future state manufacturing processes
• Assist in business process and system design; Proactively offer solution ideas and potential business process improvements in pursuit of driving efficiencies and meeting business needs
• Develop and document functional and technical aspects of integrations between the Production scheduling, MES, Manufacturing Control System (SCADA), and electronic batch record platforms
• Help create testing and validation plans; Ensure appropriate testing (i.e., Factory Acceptance Testing, Site Acceptance Testing, User Acceptance Testing, IQ, OQ, PQ, &/or Good Engineering Practice) is in place to ensure IT requirements are met.
• Work closely with Compliance, Internal Audit and Quality Assurance groups as needed to ensure compliance with GxP regulations
• Work with Enterprise Resource Planning solutions teams to define improvements and implement enhancements.
• Maintain and support existing manufacturing IT systems:
• Oversee & control the life cycle of production/manufacturing IT systems, as assigned
• Partner with offshore team members and IT peers for platform and database support
• Prepare & drive support agreements/SLAs with vendors & internal customers
• Maintain system documentation for GxP critical IT systems
• Responsible for change control & configuration management of systems
• Ensure user training & user support is in place
• Ensure data integrity & business/system continuity planning
• Lead incident & problem investigations using Lean methodology & ensure quality deviations are remediated with appropriate effective corrective actions to ensure non-recurrence
• Ensure system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Annex 11, Health Insurance Portability and Accountability Act (HIPAA), and SOX)
• Represent IT systems in connection with audits & inspections. May lead cross-functional project teams for process improvement
• Ensure continued & improved overall user satisfaction with systems
• Monitor serialization and “Track and Trace” regulatory requirements and ensure the company is compliant
• Manage all data flow across different environments for serialization data, including GS1 standards for serialization
• Enable seamless operation of Track and Trace serialization systems:
• Collaborate with external Supply Chain partners (CMO's, 3PLs, Wholesalers, Distributors, Customers) for real time visibility to support serialization activities
• Assist in technical problem solving to resolve technical and compliance issues and propose process improvements to streamline operations
• Provide support for packaging and labeling product security initiatives globally. Collaborate on qualification protocols for appropriate test design and execution
• Monitor serialization and track and trace regulatory requirements and ensure the company’s compliance
• Monitor and provide technical support for L4/L5 Serialization systems (rfxcel)
• Collaborate with Supply Chain team to enable new partner and product set up in ERP/MDM/Serialization system
• Investigate and verify negative responses to salable return verification requests

• Bachelors Degree (BA/BS) in IT/ Supply Chain/ Engineering or equivalent combination of experience & education - Required
• Master Degree (MS/MA) in Related field - Preferred

• 10 years or more Experience with systems integrations to LIMS, CMMS, DMS, QMS platforms - Required
• 10 years or more Knowledge in approaches and trends to enable Industry 4.0, lean manufacturing, digital manufacturing, etc - Required
• Minimum of five (5) years of pharmaceutical industry experience (GxP) - Required
• Minimum of five (5) years of supporting & troubleshooting automation/IT systems & batch processes - Required
• 10 years or more Knowledge of pharmaceutical and/or biotech manufacturing processes - Required
• 10 years or more Functional knowledge of API processes & batch sequencing - Required
• 10 years or more Experience in regulatory audits & inspections - Required
• 10 years or more Experience of supply chain processes - Required
• 10 years or more Expert in GxP documentation practices - Required

• Expert in system development & lifecycle management including validation of computer systems, operation & maintenance & retirement
• Familiarity with incident management, contract/SLA Management, data integrity/retention/archive, continuity/recovery plans
• Experience working with managed services and/or offshore teams
• Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components
• Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11
• Experience in project teams driving deliverables, tasks, & activities for computer system validation
• Experience in computer system validation, execution of testing, resolving of defects in a GxP environment
• Experience with ERP integrations and shop floor equipment integrations; in particular from production routings to material management
• Experience with analytical tools and platforms to document and analyze business process flows, business requirements, functional requirements
• Highest personal and professional integrity and strong work ethics
• Ability to articulate vision of transformation efforts and a sense of mission
• Willingness to take change and provide direction
• Results orientation, willingness to commit to a direction and drive operations to completion
• Demonstrated ability to manage adversity and challenging situations
• Communication, collaboration, and problem solving
• Strong communication, interpersonal and collaborative skills
• Ability to manage senior relationships across all the Business and Functional areas
• Experienced and self-directed individual able to work independently and collaboratively in matrixed team environment
• Ability to lead business users / stakeholders to complete assigned workstream tasks in a timely manner and with expected level of quality
• Ability to handle complaints, settle disputes and resolve conflicts and negotiate with others
• Collaborative team player orientation towards work relationships, strong culture awareness
• Solid analytical and problem-solving abilities
• Able to work in an open office environment with the possibility of frequent distraction
• Able to work the hours necessary to support a 24/7 continuous manufacturing operation
• Project Oversight and Decision-ing
• Highly developed skills in priority setting and alignment of project priorities with Departmental strategy
• Ability to break down complex problems and projects into manageable goals
• Ability to get to the heart of the problem and make sound and timely decisions to resolve problems

• 2 years or more in Track and Trace/Serialization
• 5 years or more in IT, Manufacturing and Supply chain background
• 3+ years’ experience and in-depth knowledge of cGMP requirements of the Global Supply Chain Security program, including Serialization, Track-and-Trace, e-pedigree, Anti-counterfeiting technology, and Product Authentication –
• Ability to read/write EPCIS(XML) files and understanding of GS1 standards
• Good understanding of database application such as MSSQL, MYSQL, Oracle and should have worked and provided technical input on Packaging line systems such as Systech, ACG and Optel.
• In-depth knowledge of the Drug Supply Chain Security Act (DSCSA)