Pharma Process Engineer II: GMP & Validation

Creative Solutions Services, LLC; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC in Bloomington, IN is seeking a Process Engineer II to optimize production processes and ensure quality and regulatory compliance across operations. You will partner with Operations, Quality, Maintenance, and Engineering teams to drive efficiency and reliable manufacturing outcomes.

Responsibilities include troubleshooting, data analysis, procedure development, validation leadership, and collaboration on CAPAs and deviations to sustain continuous improvement and

Qualifications

• 3–5 years of manufacturing or process engineering experience.
• Experience in pharmaceutical, biotechnology, or medical device industries.
• Knowledge of Lean Manufacturing principles.
• Experience with process validation activities.
• Bachelor's Degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering.

Responsibilities

• Support daily manufacturing operations and troubleshoot process issues.
• Analyze production data to identify process improvement opportunities.
• Develop and update manufacturing procedures and work instructions.
• Lead process validation and equipment qualification activities.
• Collaborate with Quality on deviation investigations and CAPAs.
• Monitor KPIs and recommend corrective actions.
• Support technology transfer and new product introductions.
• Participate in risk assessments and continuous improvement initiatives.
• Ensure compliance with GMP, FDA, and company policies.
• Provide technical support to manufacturing personnel.

Skills

GMP Compliance

Process Validation

Root Cause Analysis

CAPA

Technical Documentation

Data Analysis

Cross-functional Collaboration

Problem Solving

Education

Bachelor's Degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering

Job description

Creative Solutions Services, LLC in Bloomington, IN is seeking a Process Engineer II to optimize production processes and ensure quality and regulatory compliance across operations. You will partner with Operations, Quality, Maintenance, and Engineering teams to drive efficiency and reliable manufacturing outcomes.

Responsibilities include troubleshooting, data analysis, procedure development, validation leadership, and collaboration on CAPAs and deviations to sustain continuous improvement and