Harba Solutions Inc.
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Base pay range
$95,000.00/yr - $130,000.00/yr Job Responsibilities Develop and review PFDs, P&IDs, GA layouts, and equipment specifications in collaboration with A/E and EPC teams. Lead commissioning and qualification (CQV) activities for sterile injectable systems including formulation, aseptic filling, isolators, CIP/SIP systems, and packaging lines. Execute FAT, SAT, IQ/OQ/PQ protocols in compliance with cGMP, FDA, and EMA standards. Troubleshoot technical issues during commissioning and provide on-site support for installation and system integration. Oversee punch-list resolution and drive continuous improvement initiatives using Lean and Six Sigma methodologies. Support procurement and vendor coordination for equipment delivery and installation. Prepare and manage CQV documentation, including SOPs, batch records, validation protocols, and change control. Interface with cross-functional teams including QA, validation, HSE, maintenance, utilities, and manufacturing. Provide technical guidance, staff training, and support formal handovers to operational teams. Utilize data management tools and performance metrics to analyze trends and improve system efficiency. Qualifications Bachelor’s degree or higher in Chemical, Mechanical, Bioengineering, or related engineering/scientific field. 3–5+ years of experience in commissioning, CQV, or process/project engineering within biopharmaceutical, pharmaceutical, CDMO, or other GxP-regulated environments. Strong understanding of PFDs, P&IDs, GA layouts, equipment specs, and process features. Proven experience with commissioning and validation of sterile/aseptic systems. Familiarity with FDA/EMA GMP, ISPE guidelines, ASTM standards, and ISO regulations. Proficient in Lean Manufacturing, Six Sigma, TPM, and continuous improvement methodologies. Strong analytical, problem-solving, and communication skills with a risk-based thinking approach. Practical knowledge of electro-mechanical systems and HSE/Quality Management Systems. Skilled in data analysis, document management, and use of ERP and industry-specific IT tools. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance, Science, and Research Industries Chemical Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Harba Solutions Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Process Engineer” roles.
Indianapolis, IN $80,000.00-$87,000.00 1 month ago Indianapolis, IN $115,000.00-$140,000.00 1 month ago Indianapolis, IN $85,400.00-$158,600.00 2 weeks ago Indianapolis, IN $130,000.00-$160,000.00 1 day ago Crawfordsville, IN $90,000.00-$100,000.00 3 weeks ago Indianapolis, IN $110,000.00-$140,000.00 15 hours ago Indianapolis, IN $99,987.00-$162,479.00 1 week ago Indianapolis, IN $95,000.00-$105,000.00 2 days ago Process Engineer - Lilly Medicine Foundry
Lebanon, IN $64,500.00-$167,200.00 4 hours ago Lebanon, IN $63,000.00-$162,800.00 2 weeks ago Indianapolis, IN $81,680.00-$108,906.67 1 hour ago Sr. Process Engineer - Contract Manufacturing (Med Device)
Indianapolis, IN $64,500.00-$167,200.00 3 weeks ago Process & Project Engineer - Manufacturing
Indianapolis, IN $80,000.00-$160,000.00 2 weeks ago Entry Level Water/Wastewater Process Engineer
Indianapolis, IN $63,000.00-$93,000.00 21 hours ago Sr Process Engineer - Device Contract Manufacturing
Indianapolis, IN $64,500.00-$143,000.00 3 weeks ago Indianapolis, IN $64,500.00-$167,200.00 1 day ago Indianapolis, IN $64,500.00-$167,200.00 3 weeks ago Indianapolis, IN $71.42-$71.42 2 weeks ago Third Shift Process Engineering Specialist
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$95,000.00/yr - $130,000.00/yr Job Responsibilities Develop and review PFDs, P&IDs, GA layouts, and equipment specifications in collaboration with A/E and EPC teams. Lead commissioning and qualification (CQV) activities for sterile injectable systems including formulation, aseptic filling, isolators, CIP/SIP systems, and packaging lines. Execute FAT, SAT, IQ/OQ/PQ protocols in compliance with cGMP, FDA, and EMA standards. Troubleshoot technical issues during commissioning and provide on-site support for installation and system integration. Oversee punch-list resolution and drive continuous improvement initiatives using Lean and Six Sigma methodologies. Support procurement and vendor coordination for equipment delivery and installation. Prepare and manage CQV documentation, including SOPs, batch records, validation protocols, and change control. Interface with cross-functional teams including QA, validation, HSE, maintenance, utilities, and manufacturing. Provide technical guidance, staff training, and support formal handovers to operational teams. Utilize data management tools and performance metrics to analyze trends and improve system efficiency. Qualifications Bachelor’s degree or higher in Chemical, Mechanical, Bioengineering, or related engineering/scientific field. 3–5+ years of experience in commissioning, CQV, or process/project engineering within biopharmaceutical, pharmaceutical, CDMO, or other GxP-regulated environments. Strong understanding of PFDs, P&IDs, GA layouts, equipment specs, and process features. Proven experience with commissioning and validation of sterile/aseptic systems. Familiarity with FDA/EMA GMP, ISPE guidelines, ASTM standards, and ISO regulations. Proficient in Lean Manufacturing, Six Sigma, TPM, and continuous improvement methodologies. Strong analytical, problem-solving, and communication skills with a risk-based thinking approach. Practical knowledge of electro-mechanical systems and HSE/Quality Management Systems. Skilled in data analysis, document management, and use of ERP and industry-specific IT tools. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance, Science, and Research Industries Chemical Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Harba Solutions Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Process Engineer” roles.
Indianapolis, IN $80,000.00-$87,000.00 1 month ago Indianapolis, IN $115,000.00-$140,000.00 1 month ago Indianapolis, IN $85,400.00-$158,600.00 2 weeks ago Indianapolis, IN $130,000.00-$160,000.00 1 day ago Crawfordsville, IN $90,000.00-$100,000.00 3 weeks ago Indianapolis, IN $110,000.00-$140,000.00 15 hours ago Indianapolis, IN $99,987.00-$162,479.00 1 week ago Indianapolis, IN $95,000.00-$105,000.00 2 days ago Process Engineer - Lilly Medicine Foundry
Lebanon, IN $64,500.00-$167,200.00 4 hours ago Lebanon, IN $63,000.00-$162,800.00 2 weeks ago Indianapolis, IN $81,680.00-$108,906.67 1 hour ago Sr. Process Engineer - Contract Manufacturing (Med Device)
Indianapolis, IN $64,500.00-$167,200.00 3 weeks ago Process & Project Engineer - Manufacturing
Indianapolis, IN $80,000.00-$160,000.00 2 weeks ago Entry Level Water/Wastewater Process Engineer
Indianapolis, IN $63,000.00-$93,000.00 21 hours ago Sr Process Engineer - Device Contract Manufacturing
Indianapolis, IN $64,500.00-$143,000.00 3 weeks ago Indianapolis, IN $64,500.00-$167,200.00 1 day ago Indianapolis, IN $64,500.00-$167,200.00 3 weeks ago Indianapolis, IN $71.42-$71.42 2 weeks ago Third Shift Process Engineering Specialist
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr