Sr Process Engineer

MilliporeSigma; Indianapolis (IN); On-site; USD 112,000 - 168,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma is seeking a senior process engineer to execute cGMP process development for sterile injectable products. You will lead a team of engineers, support technology transfer, and coordinate projects with internal and external clients.

The role focuses on process engineering, scale-up, and transfer of new chemical processes from development to full-scale manufacturing, including optimization of PEGylated and nanoparticle formulations.

Qualifications

• Bachelor’s or higher in Chemical/Biochemical/Pharmaceutical Engineering or related field.
• 5+ years experience in pharmaceutical operations (validation/process/project engineering).
• Deep knowledge of US/EU GMP requirements and FDA guidelines.
• Experience with aseptic manufacturing, fill/finish, and related process control systems.

Responsibilities

• Provide technical support for manufacturing processes, including investigations and tech transfer.
• Lead a team of 1-5 engineers supporting process engineering and tech transfer.
• Coordinate and manage small to medium scale projects with budgeting and scheduling.
• Interface with external/internal clients and contractors on contract manufacturing opportunities.
• Develop equipment specs, drawings, and process development protocols.
• Create SOPs and update existing ones.
• Perform hydraulic, heat transfer, and material balance calculations.
• Lead process investigations and support clinical/commercial tech transfer.

Skills

GMP knowledge

Project management

Communication

Team leadership

Problem solving

Education

B.S./M.S. in Chemical/Biochemical/Pharmaceutical Engineering or related field

Tools

Microsoft Project

Minitab

Jump

Microsoft Visio

AutoCAD

Job description

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.

Your Role

Responsible for executing business unit driven process development programs using practical application of fundamental engineering principles in a cGMP setting associated with sterile injectable products. Responsible for providing key engineering/technical support and project coordination as well as overseeing a team of engineers. Responsible for interfacing with internal and external clients in support of product technology transfer, manufacture and investigations.

Tech Support efforts primarily focus on process engineering, scale-up and continued support for complex formulations such as PEGylated formulations as well as Liposomal and Lipid Nanoparticles (LNP) based formulations. Importantly, this specific role will help facilitate the transfer and introduction of new chemical processes from the development lab or directly from the client through to full-scale manufacture as well as technical support for the improvement and optimization of chemical processes.

Activities & Responsibilities

• Provide technical support for the manufacturing processes, including process investigations, continuous process improvements, technology transfer and scale up of new product introductions
• Leverage process knowledge/experiences to become a subject matter expert (SME) for multiple product lines (preclinical through commercial). Desired expertise in nanomedicinal complex formulations or conjugated formulations
• Mentor and lead a group of 1-5 engineers supporting process engineering, scale-up, tech transfer and product investigations.
• Coordinate and execute small to medium scale and/or complex technical projects. 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.
• Coordinate and execute tech 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 external / internal clients and contractors in support of contract manufacturing opportunities.
• 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.
• 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. Responsible for support of all types of facility projects, including clinical and commercial product tech transfer - no limit in value.

Minimum Qualifications

Who You Are

• B.S. / M.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering or related field
• Five (5) or more year’s minimum experience in pharmaceutical operations as validation engineer, process engineer, project engineer, or similar capacity. Previous experience coordinating projects and personnel is required.
• In-depth knowledge of US and European GMP requirements, FDA guidelines, and industry validation expectations is required.
• In-depth knowledge of aseptic manufacturing processes and packaging equipment, fill/finish operations, process unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process hazards and safety.

Preferred Qualifications

• 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.
• Prior experience with Lipid Nanoparticles, Liposomes, PEGylated formulations, Lyophilization unit operations and/or other nanomedicinal parenteral products is strongly preferred.
• Strong hands-on skills are desirable
• Special Training:
• Advanced PC skills with spreadsheets, word processing and databases
• Knowledge of Microsoft Project or similar project scheduling software o 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, Minitab, Jump, or similar statistical software

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.

Pay Range for this position: $112,000-$168,000

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors.

• Position may be eligible for sales or performance-based bonuses.
• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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!