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CSV Engineer

Job Title: CSV Engineer
Contract Type: Contract
Location: Basingstoke, England
Industry:
Salary: £40 - £50 per hour
Start Date: 2019-04-10
Reference: BH-106249
Contact Name: Daniel Leach
Contact Email: Daniel.Leach@nesgt.com
Job Published: April 11, 2019 17:23

Job Description

I am working with a global Pharmaceutical company based in Basingstoke who have an exciting opportunity for a CSV Specialist on a 2 year assignment 

Position Description:
The ISQ Representative is responsible for ensuring functional areas, projects, and/or systems for which they are assigned are in compliance with Computer System Validation (CSV) standards.  The role must provide independent compliance and quality oversight for the areas they support.  This includes facilitating and gaining alignment (both business and IT) on implementing a risk based approach for validating computer systems or qualifying platforms. Using comprehensive business and technical knowledge the associate provides consulting and interpretation of Elanco Quality Standards and Elanco Functional Procedures by setting validation approach based on risk, consulting on ITC processes and services, providing consultation on CSV, and maintaining awareness of corporate and external standards as they relate to CSV.  The associate makes quality decisions that impact a range of standard and nonstandard operational, process, project and services.

General IT Compliance and Quality Support:
·         Drive compliance culture within the business area or discipline
·         Build key relationships with business partners to ensure an overall state of compliance is achieved and maintained
·         Consulting with Functional Areas regarding Quality Management System components, e.g.,
o   CAPA management
o   Periodic reviews
o   Personnel qualification
o   Document management
o   IT privacy
o   Information Security
·         Participate in self-inspections, audits, and supplier assessment activities to ensure the state of Computer System Validation is clearly and accurately understood
·         Provide periodic status and compliance updates to IT areas supported and supervision
·         Provide oversight and direction to the supplier and to maximize the deliverable work performed by the supplier
·         Understand customer, company, and Quality priorities

Deliver Projects, Programs, and Support
·         Provide initial project engagement and facilitate validation risk assessments to drive solutions in a quality focused manner
·         Gain support and ensure System Owners, System Custodians, and project team members are knowledgeable of and engaged in fulfilling their responsibilities in defining, producing, approving deliverables
·         Provide consulting and CSV interpretation as related to the supported computer systems
·         Establish key relationships with Business, Business Quality, and IT customer areas to deliver business value for products, processes, and services across the business area
·         Provide leadership and guidance in driving activities to ensure that IT validation deliverables and other release commitments are completed per the project schedule.
·         Partner with suppliers of computer systems or services to ensure they meet quality expectations
·         Orchestrate the creation and maintenance of CSV deliverables for supported areas, including adhoc review and potential authoring of key deliverables based on the area’s risk and maturity
·         Escalate computer system quality issues to the appropriate persons
·         Understand and communicate the value of CSV
·         Understand customer, company, and Quality priorities
·         Provide oversight and ensure regulated and critical systems are validated in compliance with regulations and standards for computer systems.
·         Review and/or approve documents per CSV expectation within agreed service levels, or clearly communicate when activities will be completed. 
 
Streamline and Continuously Improve
·         Escalate issues appropriately
·         Promote and advocate for common process and best practice across functions
·         Identify and pursue opportunities for streamlining and right-sizing that impact multiple functions. This may include elimination of non-value added activities.
·         Identify systemic issues and trends across functions
·         Partner with business, business quality, and IT customer areas to deliver business value

Grow Capabilities and Knowledge
·         Share lessons learned and best practices with others 
·         Act as an engaged team member
·         Grow capabilities of those performing CSV activities
·         Deliver training programs to increase understanding/knowledge of CSV

Minimum Requirements:
·         Bachelor (4 yr College) degree in a technology-related field such as Computer Science or Engineering, or equivalent experience
·         Proficiency with IT systems development life cycle and IT best practices (e.g., ITIL, Agile, etc)
·         Proficiency with Computer Systems Validation and demonstrated ability to right-size validation based upon risk
·         Comprehensive business and quality technical knowledge
·         Previous experience with implementing regulated computer systems
·         Strong oral and written communication and interpersonal interaction skills
·         Ability to influence quality peers, IT SMEs, and management
·         Ability to drive solutions for products, process, and services across a business area
·         Ability to focus across multiple processes (end-to-end viewpoint)

Additional Preferences:
·         Broad IT technical competency 
·         Project management skills
·         Previous experience in regulated (e.g., GMP, GLP, GCP, SOX) environment
·         Knowledge of Elanco business area
·         Ability to relate system use to potential impact to products)
 
For more information please contact -

Daniel Leach

+44 161 942 7137 
daniel.l.a2tui2h6e@nesgt.aptrack.co.uk