Validation Engineer

Job Description

Hiring Validation Engineer.

NO C2C ONLY W2

Qualifications

Bachelor’s degree (preferably in an engineering discipline) or relevant engineering, scientific or related discipline

2+ years professional experience in a biologics/pharmaceutical

Experience developing and executing process, equipment, and cleaning validation protocols

Knowledge of cGMP practices and standards

Excellent written and verbal communication and interpersonal skills; prefer an individual with a positive, results oriented, team mindset and capable of changing direction and focus as priorities shift

Responsibilities

This individual will write and execute validation protocols for new and existing, facility utilities, and process equipment

Write and execute validation protocols for new and existing equipment, facility utilities, and manufacturing processes

Start-up C&Q experience of process and utility systems

Be able to work as part of a large project team and be a system owner for a system

Role will involve authoring and executing CQV documentation for a defined system against project schedule and timelines

Provide direction, input, review and approval of engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems, and utilities to ensure thoroughness, accuracy and compliance with company policies

Provide technical troubleshooting and creative solutions to manufacturing process challenges

Thanks

Suchi

203-446-4148Company Description

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.