Engineering Project Lead

ZipRecruiter; Menlo Park (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Engineering Project Lead to oversee sterile product projects. The ideal candidate will have extensive experience in pharmaceutical project management and engineering, ensuring compliance with industry standards. This role involves coordinating engineering projects, supervising teams, and managing vendor relationships. The company offers competitive pay and comprehensive benefits, fostering a supportive environment for professional growth.

Benefits

Competitive salary based on experience

Annual bonus eligibility

Comprehensive benefits including medical, dental, and vision coverage

Paid time off

401(k) savings plan

Qualifications

• Minimum 8 to 10 years of experience in pharmaceutical projects.
• Experience in sterile manufacturing and packaging.

Responsibilities

• Coordinate multidisciplinary engineering projects throughout their lifecycle.
• Supervise daily activities of the project team, including contractors and suppliers.
• Manage planning and execution of critical success factors.

Skills

Project management skills

Effective time management

Problem-solving skills

Strong interpersonal skills

Excellent written and verbal communication skills

Education

BE in Mechanical or Chemical Engineering

Tools

AutoCAD

Job description

Job Description

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 involving sterile products such as vials, PFS, cartridges, and IV bags. They should have hands-on experience in executing sterile projects, concept designing, and basic engineering for pharma projects. Familiarity with relevant guidelines like cGMP, GSP, GLP, ISO, etc., is essential. The candidate should be a self-starter, motivator, and team player, capable of independently managing vendor and supplier relationships, internal stakeholders, project management, scheduling, master planning, project progress reporting, and management reporting activities. Knowledge of site execution, installation, and commissioning is mandatory.

Responsibilities:

• Assist the Project Director with project-related tasks.
• Coordinate multidisciplinary engineering projects throughout their lifecycle—from proposals to final handovers—within scheduled and agreed timelines.
• Ensure the use of proper engineering procedures, methods, and technical solutions throughout the project.
• Supervise daily activities of the project team, including contractors and suppliers.
• Manage planning and execution of critical success factors such as scope, time, cost, and quality.
• Review vendor proposals against standards and guidelines; develop deviation and correction reports for communication with suppliers and contracts.
• Coordinate with city and county authorities regarding facility design and approval in accordance with local regulations.
• Review consultant designs to ensure compliance with cGMP standards.
• Upon project completion, this role will transition to Head of Plant Engineering and Maintenance.

Qualifications:

Education:

• BE in Mechanical or Chemical Engineering from a reputed university.

Experience:

Minimum 8 to 10 years of professional experience in pharmaceutical projects or process design within a pharmaceutical company or engineering/consulting firm, including:

• Sterile manufacturing and packaging.
• Review and implementation of clean utility systems.
• Execution of HVAC systems for sterile plants.
• Setting up greenfield pharmaceutical projects.
• Basic knowledge of electrical, instrumentation, and process engineering.

Knowledge, Skills, and Abilities:

Functional:

• Knowledge of sterile formulation engineering.
• Familiarity with USFDA, cGMP, GLP, ISPE, ISO standards.
• Proficiency in AutoCAD.
• Project management skills.
• Planning and execution capabilities.

Behavioral:

• Result-oriented mindset.
• Innovative thinking.
• Effective time management.
• Problem-solving skills and high self-motivation.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.

Requirements:

• Valid driver's license and acceptable driving record.
• Legally authorized to work in the United States (U.S. or permanent residents).
• Willing to reside in or relocate to the Sacramento Metropolitan Region (within approximately 40 miles).

Benefits:

• Competitive salary based on experience.
• Annual bonus eligibility.
• Comprehensive benefits including medical, dental, and vision coverage.
• Paid time off.
• 401(k) savings plan.

Additional Information:

Nivagen is committed to equal employment opportunities for all individuals, regardless of factors such as race, gender, age, disability, ancestry, citizenship, political affiliation, gender identity, marital status, parental status, veteran status, genetic information, or other legally protected characteristics. We prohibit harassment and retaliation based on any of these factors.