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