Kelly Services is actively recruiting for a Process Engineer for a Direct Hire opportunity in Greater Indianapolis area, IN.
Responsible for providing key engineering support and project coordination to all phases of plant operations. Responsible for interfacing with internal and external clients in support of product technology transfers and manufacture. Responsible for technical support for processes and product investigations
Major Position Activities & Responsibilities:
• Provide technical support for the manufacturing processes, including process investigations, continuous process improvements, technical transfer and scale up of new product introductions.
• Apply process knowledge and experiences to become a subject matter expert (SME) for multiple product lines (preclinical through commercial).
• Coordinate and execute technology transfer projects in support of new clinical and commercial Client products and contract manufacturing opportunities. In addition to project management responsibilities described above, individual will be the main technical interface with externa/internal clients and contractors in support of contract manufacturing opportunities. Coordinate with multiple departments (both internal and external) to manage project deliverables
• Coordinate and execute small to medium scale and/or complex technical projects up to $250K in value. Associated functions include process and equipment design engineering, project estimating and budgeting, developing capital appropriation requests, documentation updates, scheduling and overall project coordination and oversight. Project staffing will be comprised of personnel from various departments on-site, as well as contract personnel. Individual will be required to coordinate multiple projects of varying scope and size concurrently.
• Provide project and process engineering support for technical projects. Associated tasks include equipment specification and procurement, process development, drawing development, protocol development and execution.
• Interpret, modify and create engineering drawings, including Piping and Instrumentation Diagrams, Piping Drawings, Layouts, Isometrics, Building Mechanical, Instrumentation and Electrical Drawings.
• Creation of Standard Operating Procedures (SOPs) for new equipment/processes, as well as update of existing SOPs.
• Perform process and utility calculations as related to hydraulic design, heat transfer, material balances, etc.
• Develop new and modify existing control loops/strategies. Create and interpret PLC control ladder logic
• Research, write, coordinate, and execute validation protocols including IQ, OQ, PQ for process, equipment, facility, utility, computer, and cleaning validation. Execute validation test functions in support of approved protocols. Review, summarize and present data in a Summary Report for management review and approval. Perform revalidations.
• Lead and provide technical support for process investigations
• Performs special projects and other duties as assigned.
• The individual will be required to lead and supervise a project-defined team comprised of personnel from all facility departments as well as outside contractors. Responsible for small to medium scale project budgets up to $250K in value. Responsible for support of all types of facility projects, including clinical and commercial product tech transfer - no limit in value. Project reporting is a dotted line structure with respect to specific project responsibilities only. Responsible for no direct staff.
o B.S. / M.S. in Chemical or Biochemical Engineering
o One or more year's minimum experience in pharmaceutical operations or similar industry as validation engineer, process engineer, project engineer or similar capacity.
o Knowledge of US and European GMP requirements, FDA guidelines, and industry validation expectations is required.
o Knowledge of aseptic manufacturing processes and packaging equipment, unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process hazards and safety.
• Strong hands-on skills are desirable.
o Advanced PC skills with spreadsheets, word processing and databases
o Knowledge of Microsoft Project or similar project scheduling software
o Previous training in project management skills, Kepner-Tregoe or another program
o Knowledge of Root Cause Analysis methodology, FMEA or another program
o Knowledge of Microsoft Visio, AutoCAD, or similar drawing program
o Knowledge of Minitab, Jump, or similar statistical software
• Personal Skills: Employee must be self-motivated, highly organized, and conscientious. Effective interpersonal skills are required to interface with internal and external clients as well as outside contractors. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Strong verbal and written communications skills are required. Must be well organized to effectively coordinate multiple projects concurrently. Strong mediation skills are essential in gaining and maintaining cross-departmental project support.
• Employee must be available to work hours outside of the standard operating shift on occasion as required to maintain the production schedule.
• Physical Requirements: Employee must have sufficient mobility to work in a process environment. The employee will be required to climb stairs and ladders to perform the functions of this job
If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.Why Kelly®
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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