KKR Consulting
We are seeking an experienced
Industrial Engineer
with a strong background in the
Medical Device and Pharmaceutical manufacturing environment . The role involves optimizing production processes, improving efficiency, and ensuring compliance with regulatory standards (FDA, cGMP, ISO 13485).
Key Responsibilities
Analyze and improve
production workflows , equipment layouts, and manufacturing processes to enhance efficiency and quality.
Conduct
time and motion studies , capacity analysis, and process mapping.
Implement
Lean, Six Sigma, and continuous improvement methodologies
to reduce waste and variability.
Collaborate with cross-functional teams (Manufacturing, Quality, Supply Chain, R&D).
Support
validation and documentation activities
(process validation, equipment qualification).
Develop and maintain
standard operating procedures (SOPs)
and work instructions.
Monitor key performance metrics (OEE, throughput, defect rates) and identify improvement opportunities.
Participate in
new product introduction (NPI)
and process scale-up activities.
Ensure all improvements meet
FDA, cGMP, and ISO
compliance requirements.
Qualifications
Bachelor’s or Master’s degree
in Industrial Engineering, Manufacturing Engineering, or related discipline.
2–5 years
of experience in
Medical Device or Pharmaceutical
manufacturing environments.
Strong understanding of
Lean Manufacturing, Six Sigma, and process optimization tools.
Experience with
process validation, risk assessment, and documentation .
Familiarity with
ERP/MES systems
(SAP, Oracle, etc.) preferred.
Excellent communication, analytical, and problem‑solving skills.
Preferred Certifications
Lean Six Sigma Green Belt or higher
Knowledge of FDA, cGMP, ISO 13485, and 21 CFR Part 820 regulations
#J-18808-Ljbffr
Industrial Engineer
with a strong background in the
Medical Device and Pharmaceutical manufacturing environment . The role involves optimizing production processes, improving efficiency, and ensuring compliance with regulatory standards (FDA, cGMP, ISO 13485).
Key Responsibilities
Analyze and improve
production workflows , equipment layouts, and manufacturing processes to enhance efficiency and quality.
Conduct
time and motion studies , capacity analysis, and process mapping.
Implement
Lean, Six Sigma, and continuous improvement methodologies
to reduce waste and variability.
Collaborate with cross-functional teams (Manufacturing, Quality, Supply Chain, R&D).
Support
validation and documentation activities
(process validation, equipment qualification).
Develop and maintain
standard operating procedures (SOPs)
and work instructions.
Monitor key performance metrics (OEE, throughput, defect rates) and identify improvement opportunities.
Participate in
new product introduction (NPI)
and process scale-up activities.
Ensure all improvements meet
FDA, cGMP, and ISO
compliance requirements.
Qualifications
Bachelor’s or Master’s degree
in Industrial Engineering, Manufacturing Engineering, or related discipline.
2–5 years
of experience in
Medical Device or Pharmaceutical
manufacturing environments.
Strong understanding of
Lean Manufacturing, Six Sigma, and process optimization tools.
Experience with
process validation, risk assessment, and documentation .
Familiarity with
ERP/MES systems
(SAP, Oracle, etc.) preferred.
Excellent communication, analytical, and problem‑solving skills.
Preferred Certifications
Lean Six Sigma Green Belt or higher
Knowledge of FDA, cGMP, ISO 13485, and 21 CFR Part 820 regulations
#J-18808-Ljbffr