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Senior Validation Engineer

2 months ago

Monroe, United States Insight Global Full time

JOB DESCRIPTION

The Sr. Specialist, MSAT will provide technical expertise to optimize commercial manufacturing processes and commercialize new products and technologies. This role is responsible for performing project activities for new product introductions into the Monroe site. This will include activities such as scale-up batches, equipment/systems qualifications, exhibit/registration batches, and process/cleaning validations. In addition, this role is involved in continuous improvements through data analysis, regulations updates and industry standards applicable to aseptic/ sterile drug products.


REQUIRED SKILLS AND EXPERIENCE

* 6+ years in Pharmaceutical Industry (FR&D/PDL/Tech. Services/MS&T). Pharmaceutical and FDA is preferred

* Bachelor's degree, preferably with a focus in Engineering or Pharmaceutical Science

* Hands-on experience in Manufacturing Operation of Sterile /Parenteral formulations and related equipment such as vial washer, tunnel, filling, capper, Lyophilizer, PFS, Manufacturing and filtration vessel, labelling, Inspection, Utilities: Water for Injection Generation and distribution, Purified water Generation , Compressed air, Pure steam & Nitrogen)

* Experience executing and writing test protocols Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) * Comprehensive knowledge of production processes


NICE TO HAVE SKILLS AND EXPERIENCE

* Experience with Trackwise

* Knowledge of Capa and Deviations