CQV Engineer
Company: Verista
Location: Greenville
Posted on: May 14, 2022
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Job Description:
Description Who are we : Looking for an exciting opportunity at
a fast growing, employee-oriented company? Verista---s 500 experts
team up with the world---s most recognizable brands in the life
science industry to solve their business needs. Whether it---s
compliance, quality management, verification, validation,
automation, IT infrastructure, data analysis, manufacturing, or
packaging, we deliver solutions that are right the first time.
Verita---s experts include SMEs across the spectrum of pharma,
medical devices and biotech industries. As a result, we---re
uniquely capable of offering transformative, integrated solutions,
new perspectives, and consistent results. Our ability to grow is
driven by world-class people who thrive in a team environment and
share our mission to enable our clients to improve the quality of
patient healthcare worldwide. Our talented and dedicated
professionals are committed to making an impact every day. We
deliver solutions that are right the first time. Typical
Responsibilities Include: Senior Validation Engineer-Data Integrity
Perform Data Integrity Assessments on Laboratory and Manufacturing
equipment Understand remediation pathways for gaps discovered
through assessments Determine and delegate tasks amongst a team to
complete assignment. Conduct impact analysis for validation and
change management Coordinate teams to complete validation testing
activities Manage complete document management and approval through
client---s process Conducts regulatory impact analysis/assessment
and, where warranted, makes recommendations Requirements A minimum
of a Bachelor---s degree in an Engineering or Scientific degree and
five to seven years industry experience. Preferred: 5-7 years---
experience in GMP regulated environment (with Internship or co-op
work experience considered as part of that experience) Previous
Data Integrity assessment experience Direct experience
authoring/editing/executing validation documents for laboratory
equipment, Manufacturing equipment and/or laboratory systems (LIMS,
ELN, CDS) Excellent knowledge of FDA regulations, ISPE guidelines
and ISO standards including: Good Documentation Practice (GDP) in
pharmaceutical environment 21 CFR Part 11 Benefits Because
employees are the key to our success, Verista offers strong
benefits and incentives including: Health, Dental, and Vision
Insurance 401(k) Retirement Plan with a company match Paid Time Off
Pay Tuition Reimbursement 9 Company Paid Holidays Paid Long Term &
Short Term Disability Insurance Training and Development Paid
Maternity Leave and Parental Leave Travel Bonus Employee Referral
Program Tuition Reimbursement Marriage Leave Bereavement Verista is
an Equal Opportunity Employer
Keywords: Verista, Greenville , CQV Engineer, Engineering , Greenville, North Carolina
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