| Hiring For CSV Engineer, Onsite in NJ at Remote, Remote, USA |
| Email: [email protected] |
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Title:- CSV Engineer Onsite in NJ CSV Engineer Responsibilities: We are seeking a skilled Computer System Validation (CSV) Specialist to support the commissioning and qualification (C&Q) efforts for a cell therapy manufacturing project. This role ensures that computer systems meet regulatory compliance standards and are validated to facilitate product manufacturing. Responsibilities Include: Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment Collaborate closely with automation and validation teams to ensure systems meet project and regulatory compliance standards Manage the document lifecycle, including creation, revision, and storage, in compliance with project documentation systems Participate in weekly project meetings to coordinate with system owners and management for alignment on project needs and issue resolution Conduct risk assessments and generate compliance reports, managing deviations and ensuring all required documentation meets quality and regulatory standards Oversee vendor interactions, including reviewing and tracking vendor deliverables and system qualifications Requirements: Bachelors degree in a relevant field (e.g., Engineering, Computer Science, Life Sciences) Minimum of 5 years of experience in Computer System Validation in a GMP-regulated environment, ideally within pharmaceuticals or biotechnology Strong knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards) and quality systems Experience with DeltaV control systems and document management systems Excellent organizational, communication, and documentation skills Ability to work effectively both independently and as part of an integrated project team Must be available to work onsite at client site in Warren, NJ (On-site; some degree of remote work possible with approval) Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the clients organization Demonstrated ability to generate CSV deliverables independently Ability to work independently and as part of a team, with the ability to transition between the two Capacity to make independent sound decisions and independently manage priorities Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities 5 years minimum of relevant experience Manish Kumar Senior Technical Recruiter : [email protected] : linkedin.com/in/manish-kumar-a04490341 Add : 30 N Gould St Ste R Sheridan, WY 82801 Website : www.mightywarners.com -- Keywords: rlang information technology New Jersey Wyoming Hiring For CSV Engineer, Onsite in NJ [email protected] |
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| 08:58 PM 21-Jan-25 |