ATL01-080823 Validation Specialist North Carolina
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Job Location:
Greenville - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group USA Inc. (V&EG USA) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to working under the highest ethics standards.
Location: North Carolina
Responsibilities:
- Follow a Risk Based Approach and Testing Strategy.
- Responsible for the overall delivery and execution of the CQV scope of work including completing all assigned CQV deliverables.
- Communicate progress on established team meetings.
- Ability to work independently while maintaining communication with all team members.
- Requires teamwork leadership and influencing skills with a strong focus on customer service.
- Exposure to typical manufacturing laboratory mechanical and warehouse environments.
Qualifications:
- Bachelors Degree in Science or Engineering.
- Minimum of 5 years of experience with commissioning and qualification of aseptic or fill/finish production and packaging systems like:
- Commissioning & Qualification of Visual Inspection Systems
- Commissioning & Qualification of Isolators
- Review and approval of validation lifecycle documentation
- Excellent communications skills (oral and written) in English.
- Excellent technical writing skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Available to work extended hours possibility of weekends and holidays if needed.
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
