Job Description

Position: Process and Automation Engineer

Client Location: Indianapolis, IN

Domestic & International Travel: Yes, 3050%

Contract Type: 6-Month Contract-to-Hire

Company: Brooksource Engineering (On-site at a pharmaceutical manufacturing client)

Compensation: $65/hour ++

Position Overview

As a Process and Automation Engineer , you will focus on defining, validating, and optimizing high-speed assembly and packaging processes for pharmaceutical products. This role emphasizes mechanical systems, process characterization, and regulatory compliance while supporting major capital projects for new product launches and capacity expansions. You will collaborate with OEMs and internal teams to ensure robust process design, seamless equipment integration, and adherence to qualification standards (IO/OQ/PQ).

Key Responsibilities

• Process Design & Optimization: Develop and refine process flows for automated assembly and packaging lines, ensuring throughput, reliability, and quality.
• Equipment Integration Oversight: Partner with OEMs to confirm mechanical and process requirements are met during design and installation.
• Engineering Studies & Characterization: Define and execute studies to characterize unit operations, establish operating ranges, and validate process capability.
• Risk Analysis & Mitigation: Apply FMEA and other risk assessment tools to identify and mitigate process and patient risks.
• Qualification & Validation: Lead or support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new equipment and processes, ensuring compliance with cGMP and regulatory standards.
• Performance Analysis: Use statistical methods and process data to identify bottlenecks, optimize cycle times, and improve efficiency.
• Documentation & Compliance: Author and maintain process documentation, including SOPs, process flow diagrams, validation protocols, and qualification reports.
• Continuous Improvement: Drive Kaizen and OPEX initiatives to enhance process reliability and reduce cost of goods.
• Mentorship: Provide guidance to junior engineers on process validation strategies and best practices.

Minimum Qualifications

• Process Engineering Expertise: Experience in mechanical assembly processes, high-speed packaging systems, and process optimization.
• Capital Project Delivery: Proven ability to support large-scale process implementation projects in regulated environments.
• Validation Knowledge: Hands-on experience with IO/OQ/PQ protocols and execution.

Preferred Qualifications

• Familiarity with cGMPs , commissioning, and qualification processes.
• Experience with DOE, GR&R , and statistical analysis for process improvement.
• Understanding of automation systems and their impact on process performance.
• B.S./M.S. in Mechanical, Chemical, or Industrial Engineering (or equivalent experience).

Additional Information

• Travel: Up to 25% on average, with peaks exceeding 50% during major project phases.

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