Process Engineer – Greenfield Facility Startup

Intellectt Inc; Lebanon (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance with options

401(k) retirement plan (no employer-m)

PTO as per state/local laws

Job summary

Intellectt Inc. is seeking a Start-up Process Engineer for a greenfield API facility focused on peptide production. You will oversee commissioning, qualification, and startup activities, serving as the site technical representative with C&Q service providers, Operations, TSMS, and Automation from planning through handover.

You will review protocols, participate in safety reviews, and provide hands-on field support for equipment setup and testing. Shift work may be required during startup.

Qualifications

• Experience in pharmaceutical or API manufacturing process engineering.
• Hands-on equipment commissioning and startup support.
• Strong understanding of process safety and operation.
• Ability to review protocols and turnover docs.
• Willingness to work shifts during startup.

Responsibilities

• Review and approve C&Q protocols, test cases, discrepancies and turnover docs.
• Support startup, shakedown testing, installation verification and operational verification.
• Participate in mechanical completion walkdowns and identify readiness issues.
• Support safety reviews, LOTO planning and PSSR.
• Provide hands-on field support for equipment setup, operation, testing and troubleshooting.
• Investigate technical discrepancies and coordinate resolution with relevant teams.
• Apply process engineering fundamentals to evaluate equipment operation and testing results.
• Coordinate with C&Q contractors, Operations, TSMS and Automation to support schedules.
• Ensure completed systems and docs are ready for handover to site Operations.
• Follow site safety requirements and approved engineering practices.

Skills

Process engineering

Equipment commissioning

Field execution

Cross-functional coordination

Documentation review

PSSR/LOTO familiarity

Job description

Seeking a Start-up Process Engineer to support commissioning, qualification, and startup of a new greenfield API manufacturing facility supporting peptide production. The engineer will serve as a site technical representative, working with Commissioning and Qualification (C&Q) service providers, Operations, Technical Services/Manufacturing Sciences (TSMS), and Automation from initial planning through equipment handover.

Key Responsibilities

• Review and approve C&Q protocols, test cases, discrepancy reports, and turnover documentation.
• Support startup and shakedown testing, installation verification, and operational verification.
• Participate in mechanical completion walkdowns and identify issues affecting system readiness.
• Support safety reviews, Lockout/Tagout (LOTO) planning, and Pre-Startup Safety Reviews (PSSR).
• Provide hands-on field support for equipment setup, operation, testing, and troubleshooting.
• Investigate technical discrepancies and coordinate their resolution with relevant teams.
• Apply process engineering fundamentals to evaluate equipment operation and testing results.
• Coordinate with C&Q contractors, Operations, TSMS, and Automation to support execution schedules.
• Ensure completed systems and documentation are ready for handover to site Operations.
• Follow site safety requirements, cGMP procedures, and approved engineering practices.

Required Qualifications

• Process engineering experience within pharmaceutical or API manufacturing.
• Experience supporting equipment commissioning, qualification, or manufacturing startup.
• Strong understanding of process equipment, system operation, and process safety.
• Ability to review technical protocols, test results, discrepancies, and turnover documentation.
• Hands-on equipment troubleshooting and field execution experience.
• Familiarity with mechanical completion, LOTO, and PSSR activities.
• Strong communication, documentation, and cross-functional coordination skills.
• Willingness to work shifts as required during startup.

Preferred Qualifications

• Experience supporting a greenfield pharmaceutical manufacturing facility.
• Exposure to peptide manufacturing or related API processes.
• Experience coordinating with external C&Q service providers.

Benefits:

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
• Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off (PTO): No PTO other than that required by applicable state and local laws