Senior Process Engineer / Site User Representative – C&Q

Job Title: Senior Process Engineer / Site User Representative C&Q
Company: Intellectt Inc
Location: Indiana Onsite
Duration: 12+ months
Pay Rate: $40/hr - $45/hr on W2
Industry: Pharmaceutical Manufacturing

Job Summary:
Seeking a Senior Process Engineer to serve as the site's technical user representative during commissioning and qualification (C&Q). The engineer will provide technical oversight, review and approve qualification documentation, support safe startup activities, and coordinate equipment handover to site Operations.

Key Responsibilities:

• Review and approve C&Q documentation, including startup and shakedown test cases, installation and operational verification, test matrices, impact assessments, discrepancy reports, and qualification summaries.
• Provide technical oversight during equipment setup, testing, tuning, troubleshooting, and qualification.
• Participate in mechanical completion walkdowns and confirm equipment readiness for commissioning.
• Help lead safety reviews and Pre-Startup Safety Reviews (PSSR).
• Review and approve commissioning Lockout/Tagout (LOTO) plans.
• Support the safe initial introduction of water and solvents into process equipment and systems.
• Evaluate equipment performance, investigate technical issues, and oversee discrepancy resolution.
• Coordinate testing schedules and execution activities with C&Q contractors, Operations, Automation, and Technical Services/Manufacturing Sciences (TSMS).
• Confirm technical documentation and outstanding issues are addressed before equipment handover.
• Ensure commissioning and startup activities follow site safety, quality, and cGMP requirements.

Required Qualifications:

• Senior-level process engineering experience within pharmaceutical manufacturing.
• Strong experience supporting commissioning, qualification, and equipment startup.
• Experience reviewing and approving C&Q protocols, technical assessments, discrepancies, and qualification summaries.
• Strong understanding of process equipment operation, troubleshooting, and process safety.
• Experience with mechanical completion walkdowns, PSSR, and commissioning LOTO planning.
• Experience supporting initial water and solvent introduction during startup.
• Ability to represent site technical requirements and guide contractors through technical issue resolution.
• Strong technical judgment, documentation, communication, and coordination skills.

Preferred Qualifications:

• Previous experience as a site user representative or technical owner during C&Q.
• Experience supporting pharmaceutical capital projects and equipment handover to Operations.

Recruiter Contact:
Name: Uzma Kousar Mohammed
Email:

uzma.kousar@intellectt.com

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.

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.