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Alcon

Process & Application Sr Engineer - FWN

Support and execute continuous improvement projects, e.g. improve process capability, facility capacity, and process/system efficiencies while minimizing material waste. Provide support and training on system audit trail reviews, complete review of system validation status, and coordinate security reviews. Identify and support the implementation, general use, and maintenance of best practice applications for the manufacturing facility. Guide facility wide programs such as, but not limited to, continued process improvement/verification, risk management, and computer system validations. The incumbent will provide technical engineering leadership to identify, evaluate, procure, install and qualify new equipment and technologies; support and troubleshoot existing equipment for various GMP processes.

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Systems and Process Improvements

  • Support or lead problem solving related to process and/or system issues, liaising with operators, line management and support functions (e.g. Engineering, Validation).
  • Support technical deviation investigation and robust CAPA and relevant follow-up for [product/process/system] related investigations.
  • Partner with Manufacturing and Compliance to ensure the execution of the production processes and systems are in conformity with up-to-date, validated manufacturing process, approved instructions, cGMPs, Data Integrity principles, and Health Authority regulations.
  • Support and execute continuous improvement projects, e.g. improve process capability, improve capacity, minimize material waste and reworks, and process/system efficiencies
  • Support introduction of new processes or equipment as Subject Matter Expert for system related issues, reviewing User Requirements, and supporting the various phases of the investment project, throughout the system lifecycle.
  • Provide system support for Operational Technology systems to include building management, environmental monitoring, compounding, filling and packaging operations (SCADA, iFIX), TrackWise, Enterprise Resource Planning (ERP) Systems (SAP), and Electronic Document Management Systems (EDMS) Rockwell Automation PLC, Factory Talk, AssetCentre, and OSIsoft PI Historian.

System and Application Ownership:

  • Support manufacturing applications as managers or owners
  • Provide and support applications to benefit manufacturing
  • Coordinate and/or complete periodic review of validation status

Continued Process Verification (CPV), Data Trending and Statistical Analysis:

  • Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for assigned products (Critical Process Parameters (CPP), In Process Control (IPC) parameters, Critical Quality Attributes (CQA), characteristics of raw materials, etc.) using statistical analysis and conducting regular product specific data trending.
  • Utilize data trending and statistical analysis to:

oDeepen and broaden process understanding and knowledge.

oDetect issues in process capability, such as systematic quality issues.

oIdentify trends of process deviations (e.g. deviation with common root cause).

oIssue monthly/quarterly/annual data trending report.

  • Develop product and process Quality Risk Assessments.
  • Support Product Steward to investigate and resolve recurring deviations and process capability issues that emerge from data trending.
  • Support Lab group with statistical assessments on Internal Release Limits (IRLs) and Product Stability
  • Ensure data and trending is visible and communicated at shop floor level.

Risk Management:

  • Develop and drive the local risk management program in conjunction with Compliance counterparts to establish effective risk mitigation throughout the manufacturing site
  • Support routine review of risk management activities within the facility to management and facilitate working sessions with cross-functional teams as necessary
  • Author and support program improvements through use of a program master plan
  • Provide facility wide guidance on best practices in risk management

Training:

  • Own the Training Curriculum for the business process owners and system owners for manufacturing application.
  • Own and facilitate training associated with the risk management program. Provide continuous communication and support for on-going assessments across cross-functional teams.
  • Own and facilitate training related to the CPV program including introductory statistics and Minitab.
  • Assist in facilitation of training related to the local Computer System Validation program including understanding of GAMP categorization

Key Competencies and Audit Support:

  • Extensive industry experience with engineering, implementing and maintaining OT Process Control Instrumentation and/or SCADA, PLC and Industrial Networks and Laboratory Automa-tion.
  • Sound technical understanding of OT architectures, hardware architecture design, experience in the application of PLC, SCADA and industrial networking for site systems.
  • Ability to practically apply available and emerging technologies within OT engineering to deliv-er robust, reliable, commissionable, operable and maintainable plants within a regulatory en-vironment.
  • Demonstrates extensive understanding and application of process engineering principles, concepts, and practices, and standards.
  • Demonstrates proficiency in current Good Manufacturing Practices (GMPs) and safety regula-tions with knowledge of pharmaceutical aseptic solutions processes, CIP, SIP, Filling, packag-ing, process manufacturing, OEE, MTBF, and root cause failure analysis.
  • Process improvement experience, understanding of lean manufacturing.
  • Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Bachelor's degree or 10 equivalent years of directly related experience

Fluent in English

2 years directly related experience

Job ID: c82a17de8e3ea6b7c0cdae809b875707
Employment Type: Other

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