United Pharma Technologies Inc
We are seeking a Process Engineer to support pharmaceutical manufacturing operations by optimizing processes, improving efficiency, and ensuring compliance with GMP and regulatory requirements. The ideal candidate will have hands‑on experience in regulated environments and a strong understanding of pharmaceutical manufacturing processes.
Key Responsibilities
Develop, optimize, and maintain manufacturing processes for pharmaceutical products
Support process scale‑up, technology transfer, and continuous improvement initiatives
Author and execute process documentation including SOPs, batch records, and work instructions
Perform process risk assessments (FMEA), root cause analysis, and CAPA activities
Support deviation investigations and implement corrective/preventive actions
Collaborate with Manufacturing, Quality, Validation, and Engineering teams
Support process validation activities (IQ/OQ/PQ) and ongoing process monitoring
Ensure compliance with GMP, FDA, EMA, and ICH guidelines
Analyze process data and drive improvements in yield, quality, and cycle time
Support new equipment/process introduction and commissioning activities
Required Qualifications
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related field
3–7+ years of Process Engineering experience in pharmaceutical or biotech manufacturing
Strong knowledge of GMP regulations and quality systems
Experience with upstream/downstream processes, formulation, fill‑finish, or solid dosage (based on role)
Familiarity with validation, deviation management, and change control
Strong problem‑solving, documentation, and communication skills
Preferred Qualifications
Experience with FDA audits and regulatory inspections
Knowledge of Lean, Six Sigma, or continuous improvement methodologies
Experience with MES, SPC, or manufacturing data analysis tools
Prior experience in sterile manufacturing or biologics (if applicable)
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Pharmaceutical Manufacturing
Location:
Illinois, United States .
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Key Responsibilities
Develop, optimize, and maintain manufacturing processes for pharmaceutical products
Support process scale‑up, technology transfer, and continuous improvement initiatives
Author and execute process documentation including SOPs, batch records, and work instructions
Perform process risk assessments (FMEA), root cause analysis, and CAPA activities
Support deviation investigations and implement corrective/preventive actions
Collaborate with Manufacturing, Quality, Validation, and Engineering teams
Support process validation activities (IQ/OQ/PQ) and ongoing process monitoring
Ensure compliance with GMP, FDA, EMA, and ICH guidelines
Analyze process data and drive improvements in yield, quality, and cycle time
Support new equipment/process introduction and commissioning activities
Required Qualifications
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related field
3–7+ years of Process Engineering experience in pharmaceutical or biotech manufacturing
Strong knowledge of GMP regulations and quality systems
Experience with upstream/downstream processes, formulation, fill‑finish, or solid dosage (based on role)
Familiarity with validation, deviation management, and change control
Strong problem‑solving, documentation, and communication skills
Preferred Qualifications
Experience with FDA audits and regulatory inspections
Knowledge of Lean, Six Sigma, or continuous improvement methodologies
Experience with MES, SPC, or manufacturing data analysis tools
Prior experience in sterile manufacturing or biologics (if applicable)
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Pharmaceutical Manufacturing
Location:
Illinois, United States .
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