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CSV Engineer

Employer
Pharmiweb Partner Job (APAC)
Location
Melbourne, Australia
Salary
Competitive
Start date
25 Jan 2023
Closing date
26 Jan 2023

View more

Discipline
Manufacturing, Engineering
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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What makes Cognizant a unique place to work? The combination of rapid growth and an international and innovative environment! This is creating many opportunities for people like YOU - people with an entrepreneurial spirit who want to make a difference in this world.
At Cognizant, together with your colleagues from all around the world, you will collaborate on creating solutions for the world's leading companies and help them become more flexible, more innovative, and successful. Moreover, this is your chance to be part of the success story.

Position Overview:

The Computer Systems Validation Engineer will be responsible for developing and executing the Computerized System Validation (CSV) deliverables for control systems within Execution Systems (ES) and interfaces.

Main Responsibilities and Accountabilities:
  • Design, modify, develop, write, review, and implement all Computer System Validation (CSV) documents, protocols, and reports for validation and qualification work. Typical validation deliverables include Validation Plans, System Risk Assessments, Traceability Matrices, Qualification protocols, and Validation Reports.
  • Execute all Execution Systems IQ and OQ protocols in coordination with Technical SMEs. Generate and track protocol discrepancy reports to closure.
  • Coordinates all CSV activities by constant communication with affected departments; oversees and reviews validation area processes and procedures; Review and approve computer system change controls, discrepancies, CAPAs
  • Ensures cGMP/Regulatory compliance with internal/external policies and, guidelines, including internal SOP’s, departmental standards and conventions.
  • Participate in the execution of gap assessment and remediation activities for the Data Integrity initiatives within CSL manufacturing sites
  • Participate in assessing system reviews, deviations, CAPA, Changes, continuous improvement, and troubleshooting related to Execution Systems.
  • Coordinate CSV/SDLC training and education to Execution Systems teams

Requirements/Experience:
  • 7+ years experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, biotechnology, chemistry, and food industries.
  • Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for life-sciences and related best practices for compliance and risk-based approach.
  • Experience with Automation and MES projects and computer validation methodologies.
  • Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ)
  • Exposure to Execution Systems technologies, including automated data collection, historian applications (OSI PI), SCADA, automated decision control, workflow, database applications, and interfaces to ERP, LIMS, etc.
  • Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5, S88.
  • Working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized systems
  • Understanding of business and manufacturing logistics and processes.
  • Proven ability to work within and contribute to a high performing team.
  • Self-motivated, demonstrates initiative, propensity to drive change
  • Detail oriented, with strong written and verbal communication skills

Salary range: >$100,000

Next Steps:
If you feel this opportunity suits you, or Cognizant is the type of organization you would like to join, we want to have a conversation with you! Please apply directly with us.
For a complete list of open opportunities with Cognizant, visit http://www.cognizant.com/careers
Cognizant is committed to providing Equal Employment Opportunities. Successful candidates will be required to undergo a background check.

About Cognizant:
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @Cognizant.
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