Computer System Validation Engineer
Company: Renaissance LLC
Location: Lakewood
Posted on: March 20, 2023
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Job Description:
Renaissance LLC
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
Overview
The CSV Engineer will oversee the GxP computerized systems
validation and provide guidance to end-user community. The
individual ensures that GxP systems meet regulations, current
industry standards, and company procedures. This position is hands
on CSV role and this individual will interact with solution and
service providers, support or participate in internal/external
audits, and assist in FDA readiness. This position frequently
interacts with customers and other groups at the Site and
coordinates the Computer System Validation tasks.
Responsibilities
--- Guides the work efforts of consultants and other team members,
and mentors them in all areas of computer system compliance and
validation.
--- Develop and implement CSV and Data Integrity processes to
ensure compliance with GxP, GAMP, OECD and applicable regulations
in conjunction with operations counterpart.
--- Responsible for providing input for maintaining the IT Master
Inventory of Electronic Systems.
--- Lead CSV projects, provide guidance to the business users and
contractors/vendors.
--- Coordinates, performs, an assist in the development of
computerized system life cycle documentation and tasks to establish
computerized systems that meet requirements. Perform various
assessments (gap analysis, 21 CFR Part 11 assessment, GxP
assessment, and Risk assessment), prepare user requirements,
functional and configuration specifications, traceability matrix,
test scripts, validation and data migration plans, IQ, OQ, PQ and
summary reports. Other validation documentation as needed.
--- Be able to author, update/revise SOP and other documents, as
needed.
--- Assisting with issues, bugs, and deviations adequate processing
and documentation. Gather, understand and document business
objective.
--- Coordination of testing activities within the team, report
progress of testing and significance of unfavorable results.
--- Perform periodic compliance assessment to maintain data
integrity at the site.
--- Create, support and provide input into system administration
and standard operating procedures (SOPs) to ensure adequate
controls for maintaining the validated state.
--- Coordinate and execute the training of Subject Matter Experts
of electronic systems.
--- Make recommendations for improvements in laboratory
productivity and quality of data.
--- Initiate and implement change control activities in accordance
with current procedures.
--- Work with MS&T leadership, IT leadership and business units
to enhance existing procedures to further the efficiencies of
compliance execution.
--- Participate in quality and process improvement initiatives, and
project teams.
--- Contributes to the overall operations and to the achievements
of department goals.
--- Interact frequently with laboratory/manufacturing/IT/Quality
facility staff to provide expertise on equipment/software
validations. Address conditions/practices with appropriate
personnel, reports findings to QA and Operations Management.
--- Other tasks as assigned.
Qualifications
Bachelor's degree in Science, Engineering, or related field, along
with related business experience and a proven record of
achievement. A minimum of 5 years of relevant experience in the
pharmaceutical industry is required, including at least 5 years'
experience supporting compliant IT systems. Must be able speak to
all levels of the organization regarding questions or concerns
around compliance issues.
Experience / Knowledge of 21 CFR Part 11, GAMP, CSV, and CSA.
Knowledge of cGMP/GLP and 210, 211, 820 requirements.
PI208332216
Keywords: Renaissance LLC, Lakewood , Computer System Validation Engineer, IT / Software / Systems , Lakewood, New Jersey
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