• Process Engineering Scientist

    System One (New Brunswick, NJ)


    Job Title: Process Engineering Scientist

    Type: Contract

    Compensation: $60 - $65.82 hourly

     

    Contractor Work Model: Hybrid

     

    Hours: Mon-Fri(normal business hours)

    Overview

    Our client is a leading pharmaceutical company looking for an experienced Process Engineering Scientist. In this role you would be responsible for supporting pharmaceutical Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.

    Responsibilities:

    + Responsible for supporting MS&T Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.

    + Design and run experiments

    + Perform risk assessments, including but not limited to Material and Process Risk assessment, Nitrosamines Risk Assessment, Elemental Impurities Risk assessment etc.

    + Complete, analyze and present data analysis

    + Support tech transfer activities in the form of generating test plans, change controls, executing and compiling results into reports

    + Supports validation efforts in the development of validation strategies and testing plans

    + Provide input into process related investigations and complete MST investigations as required.

    + Advise on root-cause analysis of undesired trends or deviations related to process equipment.

    + Support monitoring of studies at manufacturing areas, Contract Manufacturers, as needed

    + Support the Change Control process

    + Position does handle hazardous material

    Requirements:

    + Bachelor's Degree in a Science Related field required

    + 6+ years of DP technical experience, support during experimental phase and process validation and the Pharma space for oral solids. Experience writing OSD strategies, study plans, study reports, validation protocols and reports.

    + 4+ years of expertise in data evaluation, 4+ years of expertise managing Risk Assessments

    + 5+ years of expertise working process related Investigations and change controls.

    + Experience working in or supporting pharmaceutical operations required--minimum of 4 years

    + Comfortable wearing proper PPE and working in a Laboratory -- time in Laboratory will fluctuate

    + Strong communication skills, working with a team, and accountable for their work

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

     

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.