15 Mar, 2023

Process Engineer

  • Merck
  • Indianapolis, IN, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Work Your Magic with us!

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:

As Process Engineer, you will be responsible for providing key engineering support and project coordination to all phases of plant operations. The Process Engineer is also responsible for interfacing with internal and external clients in support of product technology transfers and manufacture, as well as providing technical support for processes and product investigations.

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 Exelead 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
  • Lead and supervise a project-defined team comprised of personnel from all facility departments as well as outside contractors
  • 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
  • May be required to work hours outside of the standard operating shift on occasion to maintain the production schedule

Physical Requirements:

  • Required to climb stairs and ladders to perform the functions of this job


Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Chemical Engineering or Biochemical Engineering
  • 1+ years’ experience in pharmaceutical operations as a Validation Engineer, Process Engineer, or Project Engineer
  • 1+ years’ experience with US and European GMP requirements, FDA guidelines, and industry validation expectations


Preferred Qualifications:

  • 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
  • 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, etc)
  • Knowledge of Root Cause Analysis methodology, FMEA or another program
  • Knowledge of Microsoft Visio, AutoCAD, or similar drawing program
  • Knowledge of Minitab, Jump, or similar statistical software
  • Self-motivated, highly organized, and conscientious
  • Effective interpersonal skills to interface with internal and external clients as well as outside contractors
  • Able to work and make decisions independently as well as with a team
  • Able to work in technically and mentally demanding situations
  • Strong verbal and written communications skills
  • Strong mediation skills




What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!


Apply Now