Computer System Validation (CSV) Engineer Job at EPM Scientific, Warren, NJ

eDhDeUFPbG9IWUdyRXpZdWhZcWIxc2hnYkE9PQ==
  • EPM Scientific
  • Warren, NJ

Job Description

Position Title: Senior CSV Engineer

Role Overview: We're on the lookout for a seasoned Computer System Validation (CSV) Specialist to enhance our commissioning and qualification (C&Q) activities for a cell therapy manufacturing initiative. This pivotal role ensures our computer systems are compliant with regulatory standards, enabling smooth product manufacturing.

Key Duties:

  • Formulate and implement CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment.
  • Collaborate intimately with automation and validation teams to guarantee systems comply with project and regulatory standards.
  • Oversee the document lifecycle, from creation and revision to storage, in accordance with project documentation systems.
  • Engage in weekly project meetings to synchronize with system owners and management, ensuring alignment on project requirements and issue resolution.
  • Perform risk assessments and compile compliance reports, managing deviations and ensuring all necessary documentation adheres to quality and regulatory standards.
  • Supervise vendor interactions, including reviewing and tracking vendor deliverables and system qualifications.

Key Qualifications:

  • Bachelor's degree in a pertinent field (e.g., Engineering, Computer Science, Life Sciences).
  • At least 5 years of experience in Computer System Validation within a GMP-regulated environment, preferably in pharmaceuticals or biotechnology.
  • Extensive knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards) and quality systems.
  • Expertise in validating stand-alone computer systems, such as analytical instruments and lab equipment controlled by software.
  • Superior organizational, communication, and documentation skills.
  • Must be able to generate CSV deliverables independently.

Job Tags

Work alone,

Similar Jobs

PACSUN

Men's Design Intern- Summer 2025 Job at PACSUN

 ...025 Summer Internship Program is a 10-week opportunity beginning June 17 August 22, 2025. Title/Department Mens Design Intern Responsibilities: Assist with line guides Create Color Cads and Rollouts Organize samples and concept room... 

The Research Foundation for SUNY at the University at Albany

Postdoctoral Researcher in Synthetic Organometallic Chemistry(R24-41) Job at The Research Foundation for SUNY at the University at Albany

 ...Minimum Qualifications:Applicants should have a Ph.D. with publications demonstrating expertise in synthetic organometallic chemistry, synthetic organic chemistry, synthetic inorganic chemistry or synthetic polymer chemistry.Applicants must demonstrate an ability to... 

Softworld, a Kelly Company

ASIC/FPGA Engineer Job at Softworld, a Kelly Company

 ...Job Title: ASIC/FPGA Engineer Job Location: Canonsburg, PA 15317 (100% on-site) Onsite Requirements: FPGA VHDL Secret Clearance Job Description: Requires a bachelor's degree in electrical or computer engineering, or a related Science, Engineering... 

mjstepup

Pt Virtual Data Entry Assistant (100% Remote) Job at mjstepup

 ...We are looking for a highly organized and detail-oriented Remote Scheduler - Work From Home to support our team with scheduling, data entry, administrative tasks, and customer service. This position requires someone who thrives in a fast-paced environment, has excellent... 

ABB

Field Service Technician Job at ABB

 ...have the opportunity to execute service work as per work instructions and in accordance...  ...work model for the role is: Working from home-based office, will travel to customer sites...  ...be willing to travel up to 80% (some overnight to be expected). Candidates must already...