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Process Engineer
Process EngineerHarba Solutions Inc. • Indianapolis, IN, US
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Process Engineer

Process Engineer

Harba Solutions Inc. • Indianapolis, IN, US
17 hours ago
Job type
  • Full-time
Job description

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This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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

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    Inferred from the description for this job

    Medical insurance

    Vision insurance

    401(k)

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