CQV Engineer

Company: Verista
Location: Greenville
Posted on: May 14, 2022

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