MissionViejoRecruiter Since 2001
the smart solution for Mission Viejo jobs

CSV Engineer

Company: Mastech Digital
Location: Mission Viejo
Posted on: April 9, 2021

Job Description:

Title : CSV EngineerLocation: Mission Viejo, CAFulltime +benefits (Flexible PTO, Training and, Development Opportunities, 401(k) match, Bonus Eligibility, Medical Benefits, Paid Holidays)---Job Description

  • The Automation/CSV Engineer will act as a lead for the critical qualification and validation of automation & computer systems and equipment for GMP Production, QC and Process, and Facilities from start to finish.
  • This engineer will lead the overall execution of the Commissioning, Validation and Qualification efforts regarding initiation, budgeting, scheduling, implementation, monitoring and closure according to GMP, Novartis, Regulatory and Safety requirements for automated and computerized equipment and systems. Roles & Responsibilities
    • This Engineer will be responsible to ensure that the commissioning, qualification and validation activities of automated and computerized systems and equipment are performed according to user requirement specifications to include the development of plans, protocols and reports in alignment with SOPs, corporate policies, standards and government regulations.
    • The Automation/CSV/Equipment Validation Engineer will act as an automation and computer system domain specialist, who liaises with QA Compliance during internal audits and health authority inspections.
    • Lead major partners (Engineering, MS&T, QC and IT) in driving the qualification and validation strategy for GMP automated and computerized equipment and systems for the CGTDM East Hanover site in addition to leading interactions and relationships internally; be able to adapt to the changing requirements and needs of the business.
    • Handle Qualification oversight for complex qualification and validation activities and projects while providing timely execution, reviews and approvals.
    • Coordinates and develops strategic plans with Production, Manufacturing Science &Technology, Process Sciences, and Quality Control on automation and computer systems qualification projects and plans. Identifies the "critical to quality" parameters impacting qualification activities and reviews and approves Site Validation Master Plans, Risk and Impact Assessments as appropriate.
    • Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) as well as guidance on asset change request in consultation with change request owners to evaluate validation impact.
    • Under the direction of the Engineering Head, the Automation and CS Validation Engineer acts to build, implement and maintain up-to-date the site validation compliance program and strategy.
    • The position will author, review and approve validation protocols and reports, coordinate CSV and qualification work execution with various departments and contractors. Education & Experience
      • Bachelor's degree in Engineering discipline or engineering related field with 0-5 years exp in the life sciences industry Note: If interested please email me your resume at or call me at , EXT: 2034. Best Regards,Anil ChamoliLead Recruiter, EXT : 2034

Keywords: Mastech Digital, Mission Viejo , CSV Engineer, Engineering , Mission Viejo, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


Engineering Manager
Description: Company Description br br Join the thousands of innovators, advocates and forces who are making an impact every day at one of the biggest footwear brands in the world. Whether you love to connect (more...)
Company: Skechers
Location: Manhattan Beach
Posted on: 04/13/2021

Senior .NET Microservices API Engineer / .NET5 / AWS
Description: We strive to have our business and services
Company: Motion Recruitment Partners LLC
Location: El Segundo
Posted on: 04/13/2021

Mac Tools Seeking Mechanics - Automotive Technicians - Full Training
Description: Job title: Mac Tools Seeking Mechanics - Automotive Technicians - Full Training br br Job description: br br Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom (more...)
Company: Mac Tools
Location: Lakewood
Posted on: 04/13/2021


Collision Repair Technician
Description: Job Summary Experienced Auto Body Technician needed to repair vehicles thoroughly, safely, and profitably in a manner consistent with Caliber S.O.P., insurance partner and industry guidelines/standards. (more...)
Company: Caliber Collision
Location: San Pedro
Posted on: 04/13/2021

Mac Tools Seeking Mechanics - Automotive Technicians - Full Training
Description: Job title: Mac Tools Seeking Mechanics - Automotive Technicians - Full Training Job description: Build a Great Career and a Quality Life with Mac Tools. Feel the freedom and independence of working on (more...)
Company: Mac Tools
Location: Sierra Madre
Posted on: 04/13/2021

Veterans Preferred - Cloud Engineer
Description: Military Veterans are Encouraged to Apply. Job Title: Cloud Engineer Requisition ID: R006051 Job Description: Activision Infrastructure group is looking for a Cloud Engineer. This position will begin (more...)
Company: Activision
Location: Sherman Oaks
Posted on: 04/13/2021

Web Application Engineer
Description: Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc. As a member of the software engineering division, you will assist in defining and developing (more...)
Company: Oracle
Location: Culver City
Posted on: 04/13/2021

Sr. Process/Lithography Engineer
Description: DescriptionWe are looking for a the Sr. Process/Lithography Engineer to drive the development of new microfabrication processes, qualifying them and supporting the launch of new products. As part of the (more...)
Company: Microfabrica
Location: Los Angeles
Posted on: 04/13/2021

Electro Mechanical Engineer, Battery
Description: DescriptionXos is looking for an Electro Mechanical Engineer with designing electronic circuits with off the shelf components such as relays, contactors, controllers, terminal blocks, etc., and the wire (more...)
Company: Xos Trucks
Location: Los Angeles
Posted on: 04/13/2021

Veterans Preferred - QA Data Engineer
Description: Military Veterans are Encouraged to Apply. Job Title: QA Data Engineer Requisition ID: R006022 Job Description: The Activision Data Governance team is looking for a strong data quality engineer who is (more...)
Company: Activision
Location: Sherman Oaks
Posted on: 04/13/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Mission Viejo RSS job feeds