Manager CSV-Execution Automation Systems

Key Responsibilities

• Support the automation systems, configure interfaces, ensure compliance with global standards, write and perform validation protocols, participate in compliance inspections, hold and support risk assessments, and support investigations.
• Ensure sound technical engineering concepts are applied in all tasks.
• Perform validation activities at the Site and ensures the approach and execution aligns to J&J expectations. Scope includes IT, Execution Systems, and Laboratory Analytical systems.
• Understands industry-wide and Regulatory expectations for computer system validation and works with other members of IT and site organizations to ensure that Computerized System Validation (CSV) packages are consistent with validation plans and standard operating procedures.
• Provide input on improvement of life cycle documentation.
• Provide input on SOP development.
• Act as a high-level technical resource for implementation of policy in partnership with the quality organization(s) to ensure alignment in approach and desired acceptance criteria.
• Support the implementation and adoption of the global CSV program and remediation.
• Support data integrity implementation and remediation for systems within CSV program.
• Participate in continuous improvement efforts related to CSV program.
• Support the Execution Systems organization to achieve all CSV site and corporate goals.
• Define Computerized Systems Validation scope and ensure resources, capabilities and processes are in place.
• Could lead improvement projects related to automation or computerized systems.
• Effective tracking cost, quality, and schedule to ensure an effective management of project execution.
• Ensure programs stay on target through accurate resourcing and removing obstacles, which may involve communication at a senior level within the business and supporting partners (ie. Digital and Technical Operations and Systems (DOTS).
• Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others by developing new partnerships to optimize processes.
• Primary CSV point of contact at the site.
• Define, monitor and reports metrics and KPI.
• Lead the CSV team to deliver on key projects and Lifecycle management.

Qualifications

Education: A minimum BS Degree and/ or equivalent experience in Engineering, Science or related field; required

Experience and Skills

Required: A minimum of 8 years of experience in a manufacturing environment, preferably within the biopharmaceutical or pharmaceutical industry, including at least 2 years of proven experience in an Execution Systems, Automation, or IT role within a pharmaceutical or GMP-regulated manufacturing environment.

• In-depth knowledge of automation systems, including Emerson DeltaV, OSI Pi, Siemens PLCs, and IT infrastructure & hardware.
• Experience with MES systems, preferably Werum PAS-X, and DeltaV Batch Control.
• Strong understanding of Industrial Automation Networks and Communication Protocols.
• Familiarity with S95 level 4 systems such as ERP, Quality Systems, Data Warehouses, and CDL.
• Expertise in ISA S95 and S88 standards and their application within the Global Supply Chain.
• Knowledge of cGMP regulations related to Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11.
• Proficiency with OSI PI Historian and Werum MES.
• Expert level knowledge of change management and change control process for highly integrated recipe and IT systems

Preferred: Experience in supervision/management of people and resources. Process knowledge for Upstream, Downstream and Bio Processing Support functions. Proven understanding of GAMP 5 and other recognized industry standard methodologies

Other: This position will be located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 50%) required until the project shifts to the plant site of Wilson, NC.