What are the responsibilities and job description for the MV02-031026 CSV Specialist (Lab Equipment) position at Validation & Engineering Group?
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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 work under the highest ethics standards for the following position:
- CSV Validation Specialist (Lab equipment)
Qualifications:
- Bachelor's Degree in Science or Engineering.
- Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in direct process / laboratory areas.
- Must be fully bilingual (English / Spanish) with excellent oral 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.
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ, CSV protocols development and execution, deviations and reports generation.
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Strong knowledge of Ellab Data Loggers, Star Oddi Sensors, Keyence Microscopes, Kaye Data Loggers, X-Ray, Bar Code Verifiers.
- Experience with Kneat, CDOCS, Maximo.
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.