| Process Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: supriya, nitya software solutions [email protected] Reply to: [email protected] Hi, Hope you are doing great.! This is Supriya from Nitya Software Solutions Inc; This mail is regarding the job opportunity. Please let me know if you are interested and available for the below position. If you are interested, Please share your updated resume to [email protected] or you can reach me at 8017834423. I would appreciate if you can refer someone for this position. Job Title: Process Engineer Lead Job Type: 1-2 yrs Contract Location: Onsite Branchburg, NJ (100% On Site) Please forward me qualified resumes with rate and contact number. Primary Responsibilities Independently act as Process Engineer user representative to support Active Pharmaceutical Ingredient (API) capital project for a Monoclonal operation. The project implementation has started, and the resource will need to familiarize with work completed, design and strategy on what is pending for completion. This individual will interface with the Capital delivery team, operations team members, manage the change control, along with interfacing with other technical team members for successful implementation. Support aspects of projects from confirming mechanical and automation detailed design through system delivery to end users including system commissioning and qualification (RV/IV/OV/IQ/OQ/PQ, etc.), as necessary. Develop scope and user requirements with stakeholders that will be used as the basis for detailed design developed by a third-party engineering design firm. Hold meetings to review progress and resolve issues, as necessary, to ensure that project scope, end user requirements are being met, and impact to operations is minimized and well understood. Provide field support and coordination for construction activities (safety walkthroughs, utility shutdowns, user impacts, lockout-tagout, drawing verifications, etc.) Preparation and management of change management documentation for associated projects. Review and track to closure required engineering (specifications, submittals, drawings, maintenance packages, turnover packages, etc.) and GMP (change management, protocols, reports, procedures, etc.) documentation to closure. Develop/assist and track to closure engineering, safety, and quality standard requirements (computerized system assessments, system component impact assessments, ergonomic assessments, measurement uncertainty, etc.) Qualifications 7+ Years Process Engineer experience required. Project Management Experience Proven work experience in process engineering. Excellent technical skills. Knowledge of process related standards. Experience in process simulations. GMP experience Working knowledge of process engineering software packages. Familiarity with health and safety regulations. Analytical tinker with interpersonal skills. Proven Track Record of Project Management. Experience working in an FDA regulated environment. Education & Certifications Bachelor's Degree (BS/BA) from an accredited college or university Keywords: business analyst New Jersey |
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| Mon Sep 11 18:56:00 UTC 2023 |