Manager Computer System Validation Engineer (CSV)

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The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices. The incumbent is also accountable for the delivery and execution of the sites CSV strategy including projects and lifecycle management. The Manager Computer System Validation Engineer reports to the Site Sr. Manager Automation BioNC.

Execution Systems (ES) is a dedicated team of Automation professionals with various technical expertise responsible for the implementation validation qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the manufacturing facility. Ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.

The new facility and the production process are envisioned to be highly automated with data being shared across multiple platforms to support production from raw material receipt to disposition of the produced drug substance. Data generated at each stage of production will be shared across business information and control systems including the multivariate analysis to support predicative models for process control and disposition support.

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.

• Expert level knowledge of change management and change control of highly integrated recipe and OT Systems

• Ensure sound technical engineering concepts are applied in all tasks.

• Perform validation activities at the Site and ensure the approach and execution aligns to J&J expectations. Scope includes OT Execution Systems

• Understands industry-wide and Regulatory expectations for computer system validation and works with other members of OT 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 sites 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 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 identify continuous improvement opportunities of site validation practices.

• Primary CSV point of contact at the site.

• Define monitor and report metrics and KPI.

• Lead the CSV team to deliver on key projects and Lifecycle management.

Qualifications

Education:

• A minimum Bachelor Degree and/or equivalent degree in Engineering; required

Experience and Skills:

Required:

• Minimum 6 years of experience in a biopharmaceutical or pharmaceutical GMP manufacturing environment with direct accountability for computerized system validation (CSV) activities supporting regulatory compliance and inspection readiness; or an equivalent combination of education and experience.

• A minimum 2 years of proven experience in a GMPregulated Execution Systems Automation or IT role including authoring reviewing and approving CSV lifecycle documentation used to support FDA EMA and other global regulatory inspections.

• Indepth technical and validation expertise in automation platforms including Emerson DeltaV (including DeltaV Batch Control) OSIsoft PI Siemens PLCs and supporting IT infrastructure with handson responsibility for change control impact assessment and validation defense during audits.

• MES (preferably in Werum PAS-X) and DeltaV Batch Control experience.

• Knowledge of Industrial Automation Networks and their Communication Protocols.

• Good understanding of S95 level 4 systems and their capabilities such as ERP Quality Systems Data warehouses & CDL.

• Good understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain.

• Deep understanding of cGMP regulations related to CSV including 21 CFR Part 11 EU GMP Annex 11 and data integrity principles (ALCOA) applied in inspectionready validation strategies

• Experience in supervision/management of people and resources.

• Proven application of GAMP 5 methodologies including riskbased validation approaches lifecycle documentation and inspectiondefensible traceability across highly integrated OT and execution systems

Preferred:

• Process knowledge for Upstream Downstream and Bio Processing Support functions.

Other:

• Ability to travel up to 10% of the time; international and domestic

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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