CSV Scientific Engineer

Insight Global • West Point, PA • 2d ago

Job Description

Our Bio-pharmaceutical Client is seeking a CSV Scientific Engineer to join their team in West Point, PA. This individual will be a part of the Discovery, Preclinical and Translational Medicine Operations organization and will be responsible for supporting process automation systems in clinical and non-clinical Regulated Bioanalytic, Vaccine Modernization laboratories. This position may provide direct support to automation maintenance, system security, data management, obsolescence initiatives, and all SDLC and Compliance needs. They will work closely with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support. They will also be responsible for the successful implementation of Automation solutions, including both platform technologies and associated reporting needs as well as develop and complete appropriate system validation, Change Control and testing documentation. The Sr. Engineer will develop a suite of reporting, analytics and visualization solutions that support local clinical operations and administrative business processes; ensure automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with Current GXP requirements; And will be accountable for implementing system changes and conducting system investigations. They will have active and engaged participation in the routine operations support processes as well as supporting a culture of continuous improvement at the site. This will include trouble-shooting challenging equipment/automation issues to improve performance, engaging in vendor and IT support needs, responding to alarms, and implementing future AI/ML capabilities as available. They will be providing support or leading a small startup or existing production team providing technical assistance in fulfilling the automation requirements for the team and reviewing automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with GXP Practice and corporate safety requirements. In addition, they will be developing and supporting corrective actions for investigations related to automation systems, Using technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems and participating in compliance audits and training programs including providing client services support for business area laboratory applications.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\EEOC\KnowYourRights6.12ScreenRdr.pdf) .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

Skills and Requirements

Bachelors in Engineering, Science, IT, Robotics, or related field with 3-5 years of experience

If Masters, 1-3 years of experience

Strong interpersonal skills

SOP development and review with focus on continuous improvement

Direct experience with support of validation activities and all other associated Quality functions

Understands regulatory and compliance requirements

Root Cause Analysis skills

Experience with Computer System Validation

Knowledge of the details of automation including wiring, electrical, device selection and integrations - Master's Degree null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.

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