| Senior CSV - Validation Engineer (Pharma & Life Science) | Initially Remote | Contract at Remote, Remote, USA |
| Email: [email protected] |
| From: Shalman M, Securekloud Technologies [email protected] Reply to: [email protected] Hi , Greetings !!! This is Shalman from Securekloud !!! We do have opening for our client Role : Senior CSV / Validation Engineer Location : Initially Remote (Pleasanton, CA) Duration : Long-Term Contract Position Overview: We are seeking a highly skilled and experienced Senior Computer Systems Validation (CSV) Engineer with a strong background in Pharma & Life Sciences industry, coupled with expertise in business analysis. This individual will play a critical role in ensuring the compliance and efficiency of computerized systems used in pharmaceutical and life science organizations. The ideal candidate will possess comprehensive knowledge of CSV principles, regulatory requirements, and business processes within the industry. Key Responsibilities: Computer Systems Validation (CSV): Lead and execute CSV activities for various computerized systems including but not limited to laboratory information management systems (LIMS), electronic document management systems (EDMS), quality management systems (QMS), and manufacturing execution systems (MES). Develop and execute validation protocols (IQ, OQ, PQ) in accordance with regulatory guidelines (GxP, FDA, EMA) to ensure the integrity and reliability of computerized systems. Perform risk assessments and develop risk-based validation approaches to streamline validation efforts while maintaining compliance. Business Analysis: Collaborate with stakeholders to gather and analyze business requirements related to computerized systems. Translate business needs into technical requirements and specifications to guide system design and development. Conduct gap analysis to identify discrepancies between business requirements and system functionalities. Regulatory Compliance: Stay updated on relevant regulatory requirements and guidelines (e.g., 21 CFR Part 11, Annex 11) and ensure systems compliance with these standards. Provide guidance and support during regulatory inspections and audits related to computerized systems. Project Management: Manage CSV projects from initiation to completion, ensuring adherence to timelines, budget, and quality standards. Coordinate with cross-functional teams including IT, quality assurance, regulatory affairs, and business units to ensure alignment of CSV activities with overall project objectives. Documentation and Reporting: Prepare comprehensive validation documentation including validation plans, protocols, reports, and risk assessments. Maintain accurate and up-to-date documentation of CSV activities in accordance with company SOPs and regulatory requirements. Provide regular updates and reports on CSV status, issues, and milestones to stakeholders and management. Qualifications: Bachelors or Masters degree in Computer Science, Engineering, Life Sciences, or related field. Minimum of 5 years of experience in CSV within the Pharma & Life Sciences industry, with a strong understanding of regulatory requirements (FDA, EMA, GxP). Proven experience in business analysis, requirements gathering, and documentation. Excellent project management skills with the ability to manage multiple projects simultaneously. Strong analytical and problem-solving skills, with attention to detail. Effective communication and interpersonal skills, with the ability to collaborate across different functions and levels of the organization. Certification in relevant areas such as CSV, project management (PMP), or business analysis (CBAP) is a plus. Note: This job description is intended to convey information essential to understanding the scope of the role. It is not exhaustive and may be supplemented as necessary to fulfil the organization's needs. With Regards, Shalman M Associate - US Staffing SecureKloud Technologies Limited Direct : 510-256-5175 Email : [email protected] LinkedIn : linkedin.com/in/shalman-m-0b5b45177 Keywords: information technology California Senior CSV - Validation Engineer (Pharma & Life Science) | Initially Remote | Contract [email protected] |
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| Thu Apr 04 00:11:00 UTC 2024 |