Sr Level CSV Engineer
Menzo
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Job Details
Skills
- CSV
- Pharma
- GAMP
Summary
Location: NC
Exp: At least 8-12yrs
THIS IS A BACKFILL
Client is seeking an experienced CSV Engineer to support key validation activities at a leading pharmaceutical manufacturing site. The contractor will play a critical role in ensuring compliance with regulatory and company standards by providing validation and technical support throughout the lifecycle of various systems and processes.
Qualifications:
Degree:
Bachelor's degree in Engineering, Computer Science, or related technical field, or equivalent relevant work experience (required). Master's degree (MA/MS) preferred.
5+ years of computer systems validation experience in a pharmaceutical environment REQUIRED
5+ Years experience with regulatory requirements and industry standards including 21 CFR Part 11, GAMP5, ISO, FDA & ICH guidance documents. REQUIRED
5+ Years experience w/ Root cause analysis. REQUIRED
Experience writing technical documentation based on equipment manuals. REQUIRED
Experience in GMP pharmaceutical manufacturing REQUIRED
Strong organizational skills, with the ability to manage multiple priorities and deadlines. REQUIRED
Demonstrated success in change management initiatives. REQUIRED
Experience with standard operating procedures (SOPs) and high-level conceptual understanding. PREFERRED
Project Management or Project Lead experience is a major plus. PREFERRED
Local highly preferred
- Dice Id: RTX1db533
- Position Id: 2025-12
- Posted 30+ days ago
Company Info
About Menzo
Menzo Technologies Corp is a value based IT consulting and staffing firm providing high quality technical services to its clients at competitive prices. We combine strong functional knowledge, analytical skills and technical expertise in architecting the best fit solutions for your business, thereby maximizing the value of Information Technology to business.
A company is only as strong as its people. Human capital is the true wealth of any organization in today’s highly connected, highly competitive, dynamic business environment. Each industry has its own nuances in management styles, team culture, hiring practices, business development activities, etc. But it’s most important to look at the bigger picture to meet specific human resource needs. That's where we come in. The experts who provide specialized, value-added, custom solutions that exceed expectations.
Menzo Technologies Corp is a Technology Contracting and Recruiting Firm with offices in New jersey and India. We focus on providing employment solutions for IT, Technology, Infrastructure, Engineering and Next Generation Technologies. We work with the biggest names in technology and services across industries and verticals.
Our recruiters identify, screen and hire talent for entry-level to executive-level positions in a range of sectors. As a consultative HR partner, Menzo Technologies Corp helps businesses spot and hire the right talent from outside while helping the business retain the best talent from the inside. This is the reason we have the confidence of Tier 1 and Tier 2 software leaders, Start-Ups, Technology firms and are the most sought after firm for niche searches.
Menzo Technologies Corp has been providing expert software professionals to companies across the United States. Menzo Technologies Corp specializes in providing experts in the information technology for short term/long term contract to help our client’s complete Software developments projects on time.
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