Manager Computer System Validation Engineer (CSV)

Johnson & Johnson Innovative Medicine•Wilson, NC

2d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 site’s 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.

Requirements

A minimum Bachelor Degree and/or equivalent degree in Engineering; 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 GMP‑regulated Execution Systems, Automation, or IT role, including authoring, reviewing, and approving CSV lifecycle documentation used to support FDA, EMA, and other global regulatory inspections.
In‑depth technical and validation expertise in automation platforms including Emerson DeltaV (including DeltaV Batch Control), OSIsoft PI, Siemens PLCs, and supporting IT infrastructure, with hands‑on 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 inspection‑ready validation strategies
Experience in supervision/management of people and resources.
Proven application of GAMP 5 methodologies, including risk‑based validation approaches, lifecycle documentation, and inspection‑defensible traceability across highly integrated OT and execution systems

Nice To Haves

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

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.