U.S. Capital Project Computer Systems Validation, Senior Specialist (Hybrid)

Job Description

The Digital Foundational Services U.S. Capital Project CSV Senior Specialist role is charged with the administration of regulatory compliance programs demonstrates adherence to policies and procedures championing continuous maturity to adopt a risk based and lean approach to compliance activities.

This role reports to the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US region.

Primary Responsibilities:

• Delivery of best-in-class computer systems validation to capital projects.

• Drive the adoption of automation validation standards to capital projects.

• Liaise with site Compliance/Validation colleagues and coordinate activities across sites.

• Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC) Cyber Security and Data Integrity to ensure manufacture and supply of quality pharmaceuticals.

• Liaise with product teams/technology functions and act as an SME on computer validation for capital projects in the region.

• Provision of ongoing validation training and compliance coaching and support.

• Responsible for representing compliance activities to internal and external auditors / agencies

• Supports the development of audit responses and engages with local quality organizations on proper strategies when required.

• Responsible for Identifying and engaging in remediation of IT/OT compliance risks.

• Execute risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies

• Support local teams with quality and compliance challenges and executions on how to comply with SOPs and or policies

• Responsible for reporting challenges in execution or adherence to procedural trends due to nonconformance.

• Responsible for communication and championing changes to the SDLC policies and procedures adopted by the capital project

• Responsible to engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within Digital our Manufacturing Division.

Position Qualifications

Education Minimum Requirement:

• Bachelors degree in computer science Engineering Regulatory compliance or a related study

Required Experience and Skills:

• Minimum of 5 years supporting compliance activities in capital projects

• Extensive experience in the implementation and validation of automation systems such as DeltaV DCS PLC/SCADA MES and leading of validation teams.

• Proficient and demonstrated knowledge of regulatory requirements (21CFR part 11 EMEA Annexs 11 etc) that apply to computerized systems validation and compliance for site based as well as divisional and enterprise systems.

• Working knowledge and application of ISA S95 and S88 Standards in GxP environment

• Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Manufacturing Quality and Supply chain

• Demonstrated ability to partner with stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs.

• Outstanding written and verbal communication skills able to effectively communicate complex concepts in simple ways.

• Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including executive management business leaders IT peers and colleagues worldwide.

• Strategic thinker with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity

• Results-orientation with the proven ability and reputation for developing plans and implementing them successfully.

• Self-directed self-motivated focused leader who with little direction can fill in the gaps as to what is needed and drive expected results.

Preferred Experience and Skills:

• Post Graduate Qualification in Business Strategy or IT architecture

• Prior experience in the pharmaceutical industry with specific experience in the Manufacturing Supply Chain and Manufacturing Quality areas ideally involving cross industry collaboration to drive best practices.

• Experience in integrating real time shopfloor and lab systems at an enterprise level with appropriate levels of resiliency and performance

• Experience in manufacturing analytics systems including supply and demand forecasting biologics process modelling and advanced image analysis.

• Exposure to multiple diverse technologies and processing environments.

• Knowledge of business process re-engineering principles and processes.

• Strong understanding of application development methodologies.

Travel Requirements:

Travel requirements are 25%. Will be supporting multiple projects at the same time.

Locations are not limited to:

• West Point PA

• Durham NC

• Wilmington DE

• Rahway NJ

Frequent travel for onsite F2F with team members. Travel adjusts based on project needs.

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The salary range for this role is

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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