CSV Engineer

2 weeks ago

San Diego, California, United States Select Source International Full time
Job DescriptionJob Description

Job Title: - CSV Engineer

Location: - San Diego, CA 92121

Duration: - 12 Months of Contract, with possibilities of extension.

This is 100% Onsite and Candidate must be able to work on W2 Tax terms along with prior Medical Device/ Pharmaceutical Experience.

This position is also expected to understand and exhibit the importance of adhering to regulations (i.e. SOX, FDA, HIPAA, PCI, etc.) and is responsible for contributing to regulatory compliance.

The role is expected to cultivate, grow, and maintain core principles including, but not limited to, continuous improvement, self-organization, adaptive planning, and value driven development, using methodologies and frameworks such as LEAN, SCRUM and others. Additionally, you will possess a growth-mindset, be team-oriented, have strong interpersonal skills, and possess the ability to deal with ambiguity; applicants must also demonstrate an aptitude for team communication and collaboration.

Key Responsibilities also include:

  • Effectively assess regulatory and validation requirements for computer systems within organization
  • Identify and develop all required computer system validation deliverables including but not limited to validation plan, user and functional requirements, regulatory requirements, test strategy, IQ/OQ, deployment plan, traceability matrix, validation summary and others
  • Ensures compliance to all relevant Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
  • Experience in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance
  • Provide verification/validation activities project estimates per the department operating procedures.
  • Develop, own and execute to well defined timeline and project plan
  • Manage compliance, deliverables/templates and ensuring timely completion
  • Responsible to maintain a compliance and consistency across teams and projects across sites
  • Ensure compliance through corporate level policies, supporting tools and training
  • Create, develop, and report metrics on the ongoing and pipeline projects
  • Provide support for external and internal audit activities, including audit process expertise, information repository sources, and inspection readiness including the audit lifecycle process
  • Coordinate Cybersecurity and Data Integrity actions for sites
  • Identify gaps and actions with milestones
  • Ensure all milestones are achieved on time
  • Establish and execute to the escalation process for issues and concerns
  • Help plan and execute Lean Process Projects, as assigned, across multiple sites

Qualification:

  • Bachelor degree in Computer Science, Information Technology, Healthcare Technology, Life Sciences, or related discipline. Knowledge of regulations and standards that affect the health care industry. 5+ years combined experience in software development, validation, and/or quality systems in a regulated environment.
  • Experience in leading software validation efforts, providing software quality assurance support, providing quality system support to IT systems in GxP quality systems for IT, Pharma, or Device industry.
  • Experience with writing & executing all computer system validation deliverables
Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

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