Company: Mastech Digital
Location: Mission Viejo
Posted on: April 9, 2021
Title : CSV EngineerLocation: Mission Viejo, CAFulltime
+benefits (Flexible PTO, Training and, Development Opportunities,
401(k) match, Bonus Eligibility, Medical Benefits, Paid
- 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
- 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
- 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
- The position will author, review and approve validation
protocols and reports, coordinate CSV and qualification work
execution with various departments and contractors. Education &
- 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
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