Manufacturing Engineer: GMP & Process Optimization

Katalyst-Healthcares-; Pittsburgh (Allegheny County); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analytical thinking

Problem solving

Communication

Project management

Lean Six Sigma

GMP knowledge

Formazione

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

Descrizione del lavoro

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.