Title: CSV Engineer Location: Tampa,FL (Onsite) Duration: Long Term contract Mode Of Hire - Contract (On W2 / 1099) Job Description: This position requires a minimum of a Bachelor’s degree in an Engineering or Scientific degree.
Experience in GMP regulated environment commensurate with Job Level Differentiators defined below.
Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls).
Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
Good Documentation Practice (GDP) in pharmaceutical environment
ASTM-E2500
ISO 14971 – risk management for medical devices
ISPE Applied Risk Management for C&Q
ISPE Science and Risk Based Approach for the delivery of facilities, systems, and equipment
ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools
21 CFR Part 2XX and 8XX level regulations and interpretation as applied in the above standards.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Pharmaceutical Manufacturing
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