Manufacturing Engineer

Creative Solutions Services, LLC; Pittsburgh (Allegheny County); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Pittsburgh seeks a Manufacturing Engineer to support daily operations, optimize processes, improve equipment performance, and drive continuous improvement in a regulated environment. Responsibilities include validating processes (IQ/OQ/PQ), FAT/SAT, commissioning, CAPA, deviations and change control, plus technology transfer and scale-up.

You will collaborate across Manufacturing, Quality, Validation, Engineering and Supply Chain to ensure GMP, FDA and ISO

Qualifications

• Bachelor's degree in Manufacturing, Mechanical, Industrial, Chemical Engineering, or related field.
• 3–7+ years of manufacturing engineering experience in regulated industries (pharma/biotech/medical devices).
• Experience with process improvement, equipment troubleshooting, validation, and manufacturing documentation.
• Knowledge of GMP, FDA, ISO, CAPA, deviations, and change control.
• Strong analytical, problem-solving, communication, and project management skills.

Responsibilities

• Support daily manufacturing and production operations.
• Develop and optimize manufacturing processes for quality, efficiency, and cost.
• Troubleshoot equipment and process issues and perform root cause analysis.
• Support IQ/OQ/PQ, FAT/SAT, commissioning, and process validation activities.
• Manage/support deviations, CAPA, change controls, and non-conformances.
• Develop manufacturing procedures, work instructions, and engineering documentation.
• Drive Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
• Support NPI, technology transfer, scale-up, and process improvement projects.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and Supply Chain teams.
• Ensure compliance with GMP, FDA, ISO, and applicable regulatory requirements.

Skills

Analytical thinking

Problem solving

Communication

Project management

Lean Six Sigma

GMP knowledge

Education

Bachelor's degree in Manufacturing/Mechanical/Industrial/Chemical Engineering or related field

Job description

Summary: Seeking a Manufacturing Engineer to support manufacturing operations, process optimization, equipment performance, troubleshooting, and continuous improvement in a regulated manufacturing environment.

Responsibilities

• Support daily manufacturing and production operations.


• Develop and optimize manufacturing processes for quality, efficiency, and cost.


• Troubleshoot equipment and process issues and perform root cause analysis.


• Support IQ/OQ/PQ, FAT/SAT, commissioning, and process validation activities.


• Manage/support deviations, CAPA, change controls, and non-conformances.


• Develop manufacturing procedures, work instructions, and engineering documentation.


• Drive Lean Manufacturing, Six Sigma, and continuous improvement initiatives.


• Support NPI, technology transfer, scale-up, and process improvement projects.


• Collaborate with Manufacturing, Quality, Validation, Engineering, and Supply Chain teams.


• Ensure compliance with GMP, FDA, ISO, and applicable regulatory requirements.

Requirements

• Bachelor's degree in Manufacturing, Mechanical, Industrial, Chemical Engineering, or related field.


• 3–7+ years of manufacturing engineering experience, preferably in pharma, biotech, medical device, or another regulated industry.


• Experience with process improvement, equipment troubleshooting, validation, and manufacturing documentation.


• Knowledge of GMP, FDA, ISO, CAPA, deviations, and change control.


• Strong analytical, problem-solving, communication, and project management skills.

Preferred

• Lean Six Sigma certification.


• Experience with GxP, IQ/OQ/PQ, CQV, FAT/SAT, MES, automation, or technology transfer.