Senior Commissioning & Qualification (C&Q) Project Engineer

Job Title: Senior Commissioning & Qualification (C&Q) Project Engineer
Company: Intellectt Inc.
Location: Indianapolis, IN
Employment Type: W2 Contract
Pay Rate: $70-$75/hr
Work Arrangement: Onsite
Shift: Second Shift

Job Summary:
Seeking a senior C&Q Project Engineer to serve as the client-side representative supporting the C&Q Node Lead. The consultant must independently drive assigned C&Q activities with minimal oversight.

Key Responsibilities:

• Develop C&Q strategies, schedules, qualification documents and test protocols.

• Coordinate FATs, pre-commissioning, construction turnover and punch-list closeout.

• Oversee multiple C&Q service providers and coordinate delivery across project teams.

• Manage changes, resolve execution issues and support operational readiness and handover.

• Report progress, risks and priorities to program leadership.

• Maintain an active onsite presence, including early-morning field meetings in required PPE.

Required Qualifications:

• 10+ years of commissioning and qualification experience.

• Bachelor's degree in Engineering or Science.

• Strong knowledge of applicable regulatory and qualification requirements.

• Demonstrated experience overseeing multiple service providers simultaneously.

• Ability to make decisions, resolve issues and contribute immediately.

Preferred: Pharmaceutical/biotech experience, API manufacturing CQV, projects exceeding $100 million, Kneat or similar electronic qualification platforms, 21 CFR Part 11 knowledge and a master's degree.

Key Skills: Commissioning and Qualification (C&Q), CQV strategy development, FAT, pre-commissioning, construction turnover, qualification protocols, regulatory compliance, vendor management, change control, risk management, API manufacturing, 21 CFR Part 11, Kneat, and operational readiness.

Recruiter Contact:

Rudra Prasad Kunnath
Email:

prasad.kunnath@intellectt.com

Benefits:

Employees hired into this position are eligible for benefits subject to 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 the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.