Overview
On Site
Full Time
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 6 month(s)
Skills
Attention To Detail
API
Manufacturing
Microsoft Excel
Data Analysis
Project Implementation
Reporting
Dashboard
Procurement
EHS
HSE
Collaboration
Quality Assurance
Regulatory Compliance
Documentation
GMP
Chemical Engineering
Mechanical Engineering
Instrumentation
Soft Skills
Analytical Skill
Conflict Resolution
Problem Solving
Communication
Management
Work Ethic
Leadership
Pharmaceutics
Oracle UCM
LinkedIn
Job Details
Title: Commissioning & Qualification (C&Q) Project Engineer
Location: Indianapolis, IN |Onsite
Duration: 12+ months
Role Overview:
- We are seeking a detail-oriented and proactive C&Q Project Engineer to support commissioning and qualification activities for equipment and systems in an API manufacturing facility. This role is ideal for candidates with technical expertise in facility, utilities, and API manufacturing process systems who excel in documentation, data analysis, and cross-functional coordination. The successful candidate will work under the direction of C&Q Node Leads to ensure timely and compliant project execution.
Key Responsibilities:
- Report directly to the C&Q Node Lead, providing updates on progress, risks, and issues.
- Maintain and update C&Q trackers, schedules, and dashboards.
- Review and interpret engineering drawings, specifications, and technical documents.
- Track procurement progress, equipment arrivals, installations, and system milestones.
- Participate in C&Q execution readiness and coordinate HSE activities (e.g., Permit to Work, Job Hazard Analyses, Safety Walks).
- Collaborate with cross-functional teams (QA, Engineering, C&Q Service Providers, Operations).
- Engage in field activities such as system walkdowns and ensure alignment with design and compliance standards.
- Document meeting minutes and follow up on action items.
- Ensure all documentation complies with GMP and internal quality standards.
- Perform additional tasks as assigned by the C&Q Program.
Qualifications:
- Education: Bachelor's degree in Chemical Engineering preferred; Mechanical Engineering acceptable.
- Experience: 3 5 years in commissioning and qualification (C&Q), ideally in the pharmaceutical or biotech industry.
- Technical Skills: Familiarity with piping design and instrumentation; understanding of regulatory and industry standards for C&Q.
- Soft Skills: Strong analytical, problem-solving, and communication skills; ability to manage multiple priorities in a fast-paced environment.
- Work Ethic: High integrity, ownership, and leadership; able to work independently and collaboratively.
- Industry Background: Pharmaceutical experience is strongly preferred and currently required.
Best regards,
Lavesh Kumar
| Sr. Technical Recruiter
STELLENT IT A Nationally Recognized Minority
Certified Enterprise
Phone: +1
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