What are the responsibilities and job description for the Owners Representative (Synthesis & Buffer Prep) position at i-Pharm GxP?
Job Title: Owners Representative (Synthesis & Buffer Prep)
Location: Indianapolis, IN (Hybrid, 1 week/month on-site)
Contract Type: 12-month W2-only contract
W2 ONLY contract
About the Role:
We are seeking a skilled Owner’s Representative to support the design phase of complex synthesis and buffer prep/hold skid packages on a major GMP project. This hybrid role will provide critical process engineering support, ensuring vendor design submissions meet operational, cleanability, and GMP standards. The role involves hands-on review of P&IDs, general arrangements, 3D models, and participation in FAT planning through to design closeout.
Key Responsibilities:
- Serve as the primary process engineering liaison during vendor design reviews for synthesis and buffer prep/hold skid packages.
- Review and provide actionable feedback on P&IDs, 3D models, and general arrangements.
- Support FAT planning, pre-FAT reviews, and documentation closeout.
- Ensure designs meet operability, maintainability, and GMP requirements.
- Coordinate with internal stakeholders and vendors to address design questions and resolve issues.
Qualifications:
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field.
- 5 years’ experience in pharmaceutical or biopharmaceutical equipment design, commissioning, or process engineering.
- Demonstrated experience as a User or Owner’s Representative on capital equipment packages.
- Knowledge of synthesis skids and/or buffer prep systems (vessels, transfer panels, CIP integration).
- Familiarity with vendor design review processes and GMP documentation standards.
- Strong communication skills and ability to work independently in a fast-paced environment.
Contract Details:
- 12-month W2-only contract.
- Hybrid schedule with one week per month on-site in Indianapolis, IN.