Sr. Validation Engineer- Equipment and Sterilization - Lakewood, United States - GQR

    GQR
    GQR Lakewood, United States

    1 month ago

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    Description

    Title: Sr. Validation Enginee Equipment and Sterilization

    Location: Lakewood, NJ

    Status: Full-time direct hire, onsite

    Experience: Minimum of 5 years experience with validation

    Compensation: $115,000

    This role is not set up for C2C and cannot offer any Visa sponsorship at this time.

    Description:

    Candidate will be responsible for duties associated with qualifying manufacturing and packaging equipment and Pharmaceutical facility and utilities,

    Systems include HVAC Systems, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen/argon. Facility does manufacturing of sterile and specialty pharmaceutical products.

    Responsibilities will include

    Responsible for the validation studies required for qualifying Manufacturing, Packaging equipment and Pharmaceutical facility and utilities, including: Classified areas, HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen.

    Participate in Engineering, Qualification and Validation efforts within Lakewood manufacturing, and facility support systems. Support development and enhancement of Equipment Facility and Utility qualification programs in accordance with current data integrity and cGMP best practice expectations. Oversee management of qualification protocol development. Oversee applicable computerized system administration. Ensure compliance with FDA, USP, EU, federal and state agencies, and applicable global health authorities.

    Participate in development of risk based, quality driven procedures and practices with respect to engineering, qualification and validation. Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for the site.

    Participate in the development and execution of qualification protocols for facility systems, manufacturing equipment, and laboratory instruments.

    Qualifications

    Bachelors Degree in Engineering, Life Sciences or related discipline, with a minimum of 5 years of relevant experience performing validation activities within pharmaceutical environment; or equivalent combination of education and experience.

    Knowledge of current Good Manufacturing Practice (cGMPs), GAMP 5, 21CFR Part 210, Part 211, and Part 11.