Senior Process Engineer

Merck•Indianapolis, IN

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: Responsible for providing key engineering support and project coordination to all phases of fill/finish plant operations. Responsible for interfacing with internal and external clients in support of product technology transfers and manufacture. Responsible for technical support for fill/finish processes, visual inspection operations, 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, with primary focus on aseptic fill/finish and visual inspection. Apply process knowledge and experiences to become a subject matter expert (SME) for multiple product lines (preclinical through commercial), including filling, stoppering/capping, lyophilization (as applicable), and visual inspection. Coordinate and execute technology transfer projects in support of new clinical and commercial products and contract manufacturing opportunities, including aseptic process set-up, line fit assessments, and inspection strategy alignment. 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, including fill/finish and visual inspection requirements. 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, including initiatives supporting filling lines, isolator/RABS systems, and inspection platforms. 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, with emphasis on aseptic processing equipment and inspection systems. 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, including SOPs for aseptic filling operations, line clearances, and visual inspection practices. 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. Lead and provide technical support for process investigations, including aseptic interventions, media fill support, sterility assurance topics, and inspection defect investigations. Performs special projects and other duties as assigned. Support aseptic filling in a RABS and/or Isolator environment. Manage visual inspection program for manual and semi-automated system as needed, including defect library maintenance, qualification of inspectors (as applicable), and continuous improvement of inspection performance. Support packaging systems with serialization as needed Scope: The individual will be required to lead 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.

Requirements

B.S. / M.S. in Chemical or Biochemical Engineering or equivalent scientific degree
Eight or more year’s minimum experience in pharmaceutical operations or similar industry as validation engineer, process engineer, project engineer or similar capacity, including demonstrated experience in aseptic fill/finish operations and visual inspection (manual and/or semi-automated).
Knowledge of US and European GMP requirements, FDA guidelines, and industry validation expectations is required.
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.

Nice To Haves

Knowledge of aseptic manufacturing processes and packaging equipment, unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process hazards and safety, and visual inspection defect classification and control.
Strong hands-on skills are desirable.
Advanced PC skills with spreadsheets, word processing and databases
Knowledge of Microsoft Project or similar project scheduling software
Previous training in project management skills, Kepner-Tregoe or another program
Knowledge of Root Cause Analysis methodology, FMEA or another program
Knowledge of Microsoft Visio, AutoCAD, or similar drawing program
Knowledge of Minitab, JMP, or similar statistical software

Responsibilities

Provide technical support for the manufacturing processes, including process investigations, continuous process improvements, technical transfer and scale up of new product introductions, with primary focus on aseptic fill/finish and visual inspection.
Apply process knowledge and experiences to become a subject matter expert (SME) for multiple product lines (preclinical through commercial), including filling, stoppering/capping, lyophilization (as applicable), and visual inspection.
Coordinate and execute technology transfer projects in support of new clinical and commercial products and contract manufacturing opportunities, including aseptic process set-up, line fit assessments, and inspection strategy alignment.
Individual will be the main technical interface with externa/internal clients and contractors in support of contract manufacturing opportunities, including fill/finish and visual inspection requirements.
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, including initiatives supporting filling lines, isolator/RABS systems, and inspection platforms.
Provide project and process engineering support for technical projects.
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, including SOPs for aseptic filling operations, line clearances, and visual inspection practices.
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.
Lead and provide technical support for process investigations, including aseptic interventions, media fill support, sterility assurance topics, and inspection defect investigations.
Support aseptic filling in a RABS and/or Isolator environment.
Manage visual inspection program for manual and semi-automated system as needed, including defect library maintenance, qualification of inspectors (as applicable), and continuous improvement of inspection performance.
Support packaging systems with serialization as needed