Sr Validation Engineer CSV
Sr Validation Engineer CSV
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Salary Not Disclosed
1 Vacancy
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 multifunctional 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 .
- 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 of gap assessment and remediation activities.
- Investigate and resolve exceptions nonconformances 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.
Requirements:
- Bachelors/masters degree in computer science engineering or equivalent.
- 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 softwarevendor 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.
- Quality Management System.
- Document Management System.
- Validation Management System.
Employment Type
Full Time
