Process Engineer 2

EMD Group; Indianapolis (IN); In loco; USD 67.000 - 101.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

PTO

Retirement contributions

Descrizione del lavoro

MilliporeSigma is seeking an experienced Technical Process Engineer to oversee commercial operations across bulk formulation, fill-finish, and high-speed packaging. You will lead scale‑up and transfer activities, ensuring seamless integration with existing lines and equipment.

The role requires a BS in a life science/engineering field and 2+ years of GMP/FDA experience, with preferred MS in Chemical Engineering and proficiency in MS Visio, AutoCAD, and Minitab/JMP.

Competenze

• Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering or related Life Science/Engineering field.
• 2+ years of work experience in pharmaceutical operations.
• 2+ years of work experience with US and European GMP requirements and FDA guidelines.

Mansioni

• Provide technical engineering oversight for all phases of commercial operations, including bulk formulation, fill-finish (RABS/Isolator), and high-speed packaging.
• Lead the scale-up and transfer of new clinical and commercial products, ensuring seamless integration into existing production lines and equipment.
• Manage multiple concurrent technical projects valued up to $250K, overseeing the full lifecycle from capital appropriation and budgeting to execution and staffing.
• Serve as the primary technical point of contact for internal and external clients, coordinating deliverables across cross-functional departments and contractors.
• Act as a SME to lead process investigations, identify root causes for deviations, and implement continuous improvement initiatives.
• Design and specify equipment for bulk processing and filling systems, including performing hydraulic, heat transfer, and material balance calculations.
• Author and update critical site documentation, including SOPs, P&IDs, electrical drawings, and validation protocols to ensure regulatory compliance.
• Develop and modify control loops and PLC ladder logic to optimize manufacturing equipment performance and process reliability.

Conoscenze

Process Engineering

GMP compliance

FDA guidelines

Project leadership

Formazione

BS in Chemistry/Biochem/ChE

MS in Chemical Engineering

Strumenti

Microsoft Visio

AutoCAD

Minitab/JMP

Kepner-Tregoe

Descrizione del lavoro

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

• Provide technical engineering oversight for all phases of commercial operations, including bulk formulation, fill-finish (RABS/Isolator), and high-speed packaging.
• Lead the scale-up and transfer of new clinical and commercial products, ensuring seamless integration into existing production lines and equipment.
• Manage multiple concurrent technical projects valued up to $250K, overseeing the full lifecycle from capital appropriation and budgeting to execution and staffing.
• Serve as the primary technical point of contact for internal and external clients, coordinating deliverables across cross-functional departments and contractors.
• Act as a Subject Matter Expert (SME) to lead process investigations, identify root causes for deviations, and implement continuous improvement initiatives.
• Design and specify equipment for bulk processing and filling systems, including performing hydraulic, heat transfer, and material balance calculations.
• Author and update critical site documentation, including SOPs, P&IDs, electrical drawings, and validation protocols to ensure regulatory compliance.
• Develop and modify control loops and PLC ladder logic to optimize manufacturing equipment performance and process reliability.

Who You Are

Minimum Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering or other Life Science or Engineering discipline.
• 2+ years of work experience in pharmaceutical operations.
• 2+ years of work experience in US and European GMP requirements and FDA guidelines.

Preferred Qualifications

• Master’s Degree in Chemical or Biochemical Engineering.
• Strong Microsoft Suite, Microsoft Visio, and AutoCAD skills.
• Experience with Kepner-Tregoe.
• Experience with Root Cause Analysis methodology or FMEA.
• Experience with Minitab or JMP.

Pay Range for this position: $67,300 - $100,900 / year

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. For more information.

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!