Engineering Project Lead

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834.

About the Job:

Title of the Position: Engineering Project Lead

The project lead should have a strong understanding of Pharmaceutical Projects of Sterile products like vials, PFS, Cartridges, and IV bags. Should have firm hands-on Experience in the execution of the sterile project, Concept Designing, and Basic Engineering for Pharma Projects. Well-versed with relevant guidelines like cGMP, GSP, GLP, ISO, etc. Self-Starter, motivator, team player. He/she will be independently dealing with the Vendors Suppliers, internal stakeholders apart from Project Management, Scheduling, Master Planning, Project Progress Reports, and Management Reporting activities. Knowledge of site execution, installation & commissioning is mandatory.

Responsibilities:

• Assist the Project Director with the handling of project-related tasks.
• Coordination of multidisciplinary engineering projects throughout its life cycle - from proposals to final project handovers within scheduled and agreed timeframe.
• Ensure that the proper engineering procedures, methods, and technical solutions are used throughout the project
• Coordinate or supervise the daily activities of the project team, including contractors and suppliers
• Manage the planning and execution of all critical success factors within the project such as scope, time, cost, and quality
• Review of vendor proposals against Standards and Guidelines and develop deviation and correction reports for communication with suppliers/contracts.
• Coordinate with city and county regarding facility design and approval of Pharma facilities in accordance with local rules and regulations.
• Review of Consultant designs to ensure better compliance with cGMP
• After completion of the project, this position will become Head of Plant Engineering and Maintenance

Qualifications:

Education:

• BE – Mechanical/Chemical from reputed University

Experience:

Minimum 8 to 10 years of professional experience in the field of pharmaceutical projects or process design with a pharmaceutical company Or Engineering/consulting firm.

• Sterile Manufacturing and packing
• Review and implementation of clean Utility
• Review and execution of HVAC system for sterile Plants
• Setting up a greenfield project for a pharmaceutical company
• Basic Knowledge of Electrical, Instrumentation, and Process Engineering

Knowledge, Skills, and Abilities:

Functional:

• Knowledge of Sterile formulation engineering
• Knowledge of USFDA, cGMP, GLP, ISPE, ISO
• Good Command over AutoCAD
• Project Management
• Planning & Execution     

Behavioral:

• Result oriented
• Innovative thinking
• Time Management
• Problem-solving ability & High level of self-motivation
• Strong interpersonal relationship skills
• Strong written & verbal communication skills

Requirements:

• Valid driver’s license and acceptable driving record
• Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents)
• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Benefits:

• Competitive Salary (Based on Experience)
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.