Process Engineer II

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs. With general guidance, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the manufacturing, utility, maintenance or capital projects environment utilizing engineering principles. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity. General Duties Include: Perform assignments that have loosely defined objectives that require investigation of a large number of variables. Interpret and execute policies and procedures. Recommend modifications to operating policies. Lead small group of engineers and/or technicians on an ongoing or project basis. Actively participating and providing input and feedback to the Sanofi Health, Safety, and Environmental (HSE) program to meet external regulations and internal requirements in all duties Operations Engineering Duties Include: Function as a technical resource to equipment or systems regarding troubleshooting and operations when required to meet schedules or to resolve manufacturing challenges. Routinely audit the operational performance and regulatory compliance of a large number of highly complex equipment components or systems. Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications. Design Engineering Duties Include: Execute tasks under thegeneral direction of project managers to complete design, engineering, and construction projects within schedule and budget constraints. Coordinate limited portions of the work of consultants, architects and engineering firms on development of standard design documents. Develop small to intermediate project scopes, schedules and budgets Obtain and critique quotes for system/facility modifications. Leadership Duties Include: Capable of setting priorities and leading initiatives and/or small projects. Demonstrated Skills in the following areas: Schedule development          Basic project management Collaboration Facilitation Completion and follow-up Training /Deviations /Compliance Duties Include: Utilizing quality systems to measure, analyze, and improve individual performance Partnering with peers, team members, direct and indirect management chain to ensure the following: Training Plan execution. Ensuring Inspection Readiness of assigned areas Participates in timely completion of investigations Ensuring deviation are closed in a timely manner Provides support for deviations and department documentation changes. Ensures timely completion of CAPAs. Complying with requirements from Genzyme's HSE Program Production Duties Include: Responsible for Maintaining Schedule Adherence Overseeing small departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented Monitoring projects through major milestones and completion. Obtaining additional resources from supporting departments as needed to be successful in the implementation of projects -------------------------------------------------------------------------- Basic Qualifications Bachelor's degree in Engineering, Science or related technological field 5 years of relevant work experience with 2 years' experience in operations/manufacturing environment. General understanding of Quality systems General understanding and wide application of technical principle, theories, and concepts in the Biotech/Pharmaceutical field. General knowledge of other related disciplines. General understanding of GMPs. Able to interpret CFRs in establishing current practices. Demonstrated skills in the following areas: Problem solving and applied engineering. o   Basic technical report writing Verbal communication Some Demonstrated Skills in the following areas: o  Technical presentations Personal  Organization Dealing with and managing change Basic qualifications are the minimum requirements that an individual needs to meet the needs to meet the job description. The requirements need to be quantifiable (e.g., two years of project management experience). Preferred Qualifications Degree in chemical engineering or mechanical engineering 7 years of relevant work experience with 5 years experience in operations/manufacturing   environment. Direct experience with regulated environments (i.e. cGMP, OSHA, EPA). Strong understanding of Quality systems Working knowledge of pharmaceutical/biotech processes (Cell Culture, Tangential Flow Filtration, Chromatography) Familiarity with documentation in a highly regulated environment o  Analytical Problem Solving Computer Literacy Specialized equipment/process knowledge General knowledge of C&Q , validation processes as applied to new or existing equipment Interacts with variety of communication and working styles Ability to independently determine when additional internal/external resources are required to solve problems Ability to handle multiple projects at one time Lean Manufacturing Knowledge and Experience Preferred qualifications are additional qualifications or experience that would make an individual ideal for the job. However, if the individual does not have these qualifications, it does not disqualify them from being considered for the job. Special Working Conditions Ability to gown and gain entry to manufacturing areas Support manufacturing operations on an "on call" 24/7 basis Special working conditions are specific requirements that an individual needs to perform the job requirements (e.g., 10% international travel; ability to gown and enter clean rooms). R2483431
Salary Range: NA
Minimum Qualification
5 - 7 years

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