Sr. Validation Engineer (CSV) in Oceanside, CA – Hybrid – Local Candidates

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Role- Sr. Validation Engineer (CSV)

Location- Oceanside, CA – Hybrid – Local to CA candidates

Mode of Interview– Video

 

Job Description:

Responsibilities: 

  • Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments).
  • Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans.
  • Providing leadership, oversight, and training related to validation activities to multi-functional teams.
  • Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP).
  • Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements.
  • Working with appropriate teams to establish quality expectations related to validation planning and execution.
  • Participating with stakeholders in the preparation of software specification documents, risk management and validation plans.
  • Participating in developing qualification processes and implementing standard operating procedures.
  • Participate in execution of gap assessment and remediation activities.
  • Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols.
  • Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities.
  • Preparing for and participating in external/internal computer system/software audits.
  • Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise.
  • Contributing to process improvements by developing and updating written procedures related to computer systems.

 

Skill competencies:

  • At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry.
  • Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques.
  • Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality.
  • Demonstrated project management and leadership skills.
  • Proficiency in interacting with contacts, including project teams and vendors.
  • Certified auditor or equivalent experience conducting software-vendor quality audits.
  • Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives.
  • Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP.

 

Experience with the following software systems/applications:

  • Quality Management System.
  • Document Management System.
  • Validation Management System.
  • Bachelor’s/Master’s degree in Computer Science Engineering or equivalent.

 

Thanks and Regards,

Rishant Garg


From:
Rishant,
Wise Equation Solution Inc
rishant@wiseq.net
Reply to:   rishant@wiseq.net