Senior Process Engineer, API Startup & Qualification Lead

Brooksource; Lebanon (IN); On-site; USD 103,000 - 124,000; Full time

Job summary

Brooksource is seeking a Senior Process Engineer with strong Commissioning & Qualification (C&Q) and startup experience to support a large-scale pharmaceutical expansion in Lebanon, Indiana. The role will bring systems from construction turnover through qualification, startup, and handoff to operations.

The candidate will oversee startup readiness, verify turnover documentation, and coordinate with operations, validation, automation, and project teams in a regulated manufacturing environment.

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering, or related discipline.
• 10+ years of engineering experience in manufacturing, pharmaceutical, chemical, or regulated environments.
• 5+ years in commissioning, qualification, startup, or operational readiness.
• Experience supporting capital projects from construction turnover through startup and handoff.
• Strong knowledge of C&Q processes, system qualification, and startup execution.
• Onsite work in Lebanon, IN with off-shift support when required.

Responsibilities

• Review and approve commissioning and qualification documentation.
• Support development and execution of startup and verification activities.
• Review technical changes, discrepancies, and qualification summaries.
• Verify completion of turnover packages and handover documentation.
• Participate in readiness assessments and walkdowns.
• Support startup safety reviews and testing activities.
• Review LOTO plans and safety documentation.
• Ensure safe startup and operation of systems.
• Provide technical oversight during startup and qualification.
• Troubleshoot process, equipment, and utility issues.
• Coordinate with operations, validation, automation, and project teams.

Skills

C&Q processes

Startup execution

Field leadership

Troubleshooting

Regulatory compliance

Education

Bachelor's in Chemical/Mechanical/Biochemical Eng

Job description

Brooksource is seeking a Senior Process Engineer with strong Commissioning & Qualification (C&Q) and startup experience to support a large-scale pharmaceutical expansion in Lebanon, Indiana. The role will bring systems from construction turnover through qualification, startup, and handoff to operations.

The candidate will oversee startup readiness, verify turnover documentation, and coordinate with operations, validation, automation, and project teams in a regulated manufacturing environment.