Project Engineering Lead for Biopharmaceutical Development
4 days ago
Kedrion Biopharma Inc. is a leading biopharmaceutical company specializing in the development, production, and distribution of plasma-derived products.
With over 40 years of experience in the industry, we have established a strong market presence in approximately 100 countries.
Key Responsibilities- Project Conceptualization and Execution: The Senior Project Engineer provides project engineering services for the Melville site, focusing on capital projects that align with business objectives.
- Compliance and Regulatory Affairs: Ensure that all projects adhere to relevant environmental, health, and safety regulations, as well as cGMP standards.
- Technical Expertise: Provide technical engineering and capital project management expertise for the design, implementation, and maintenance of manufacturing processes, instrumentation, and equipment.
Responsibilities Include:
- Managing project scope, user requirements, conceptual design, detailed design, installation, commissioning, validation, operations handover, and cost management.
- Performing design studies, engineering test plans, troubleshooting, submitting change control requests, and coordinating efforts with QA, regulatory, safety, production, validation, and maintenance teams.
- Preparing monthly status reports for projects, including milestones, risks, costs, and progress updates.
- A minimum of 7 years of experience in a biopharmaceutical or related industry in a role as project engineering.
- Certified Facility Manager (CFM) and/or Project Management Professional Certification (PMP) is advantageous.
- Bachelor's degree in engineering.
- Proficiency in Microsoft Office, AutoCAD, and Microsoft Project.
- Knowledge of FDA cGMPs, Federal, State, and Local Environmental regulations, standard operating procedures, QA/QC documentation, equipment validation, specifications, factory acceptance testing, site acceptance testing, start-up, and commissioning.
- Strong communication and organizational skills.
- Demonstrated ability to effectively prioritize and coordinate functions and activities.
- Excellent project management skills and comfort with project management tools.
- Problem-solving skills, results-oriented.
- Medical, vision, and dental insurance.
- Life and AD&D insurance.
- Paid holidays.
- PTO accrual.
- And more benefits, which may be reviewed upon request.
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