Associate Director, Project Engineering

Lotte Biologics USA LLC

We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

Position Summary

The role of Associate Director of Project Engineering to develop and manage the capital project portfolio for the site to ensure business goals and customer needs are met in the highly regulated CDMO (Contract Development and Manufacturing Organization) biopharma industry. They will lead and develop a high performing team of internal and external project managers and technical leads, ensuring GMPs (Good Manufacturing Practices), governing building codes, OSHA and environmental regulations, and industry regulations are met related to the manufacture of pharmaceutical products. They will work closely with the site leadership team to align capital investments with overall business strategies. The role will report to the Director of Facilities and Engineering.

Duties & Responsibilities

Responsible for the site’s portfolio of projects including capital projects, major expense projects, demolition, and abatement of hazardous materials. Project management includes all phases including feasibility studies, project scope development, design, securing permits, construction management, commissioning, and qualification.

Provides recommendations to improve and maintain facility infrastructure and takes the lead role in developing and implementing a strategic master plan for the site.

Takes an active role to bridge communication between project managers, site leadership, and customers to ensure strategy and site objectives are met.

Works closely with finance to develop the site capital budget and perform monthly and quarterly financial forecasts for the portfolio of projects and deliver against the plan.

Implements project controls to meet financial, schedule, and scope expectations including project change management, asset retirement and disposal, management of KPIs, and ensuring projects are capitalized in a timely manner to start the depreciation process.

Develops and maintains site engineering standards, specifications, and procedures for the project engineering organization to ensure consistency and compliance across projects and project managers.

Prioritizes resources/activities for Site Project Engineering and support functions. Ensure department goals and metrics are meeting or exceeding expectations. Identify deficiencies and create and execute action plans to mitigate issues.

Responsible for the performance of all reporting team members. Takes an active role in developing less experienced team members. Leverages both internal and external relationships to build the best team possible.

Manages the development and administration of operating expense budget for the Site Project Engineering department in addition to the site capital budget.

Customer service is paramount; therefore, must build and sustain strong relationships with internal and external stakeholders including Finance, Manufacturing, Quality, EHS, and local community and regulatory agencies to meet site and business requirements. Periodically will assess with the customers that the expected service level is being attained and must strive to exceed such expectations.

Uses enhanced knowledge and influence to support and grow strong company culture of Safety and Values at all levels of the organization.

Education & Experience

B.S. Degree in Engineering or related discipline required with a minimum of 8-10 years of experience in engineering/project management. Advanced degree beneficial.

Project Management Professional (PMP) certification is preferred.

Understanding of financial management related to capital projects (project cash flow and other financial metrics/KPIs)

Previous managerial experience which demonstrates proficiency in selecting, motivating, and retaining a superior team, effectively managing personnel, and planning and administering financial resources is required.

Excellent project management, communication, presentation, and technical writing skills are required.

Knowledge of pharmaceutical utility operation, cleanrooms, HVAC, pharmaceutical water systems and building systems is preferred.

Understanding of applicable regulations (GMP, OSHA, DEC, etc.).

Familiarity with quality systems governing GMP utilities and facilities (change control, SOPs, investigations, CAPAs).

Work Environment

The work environment for the job includes office space, lab space, manufacturing areas, mechanical rooms, inside work, outside work, working alone, working with and around others, noise, heights, and cramped quarters.

Physical Demands

Physical demands of the job include unassisted lifting of items, not to exceed 50 lbs; crouching/squatting; kneeling; sitting; crawling; walking on level surfaces; climbing stairs and ladders; and vision (visual inspection of installations).

The job will also require the use of PPE, such as hard hat, hearing protection, safety glasses, steeled toed shoes, and fall protection.

Supervisory Responsibilities

Managerial responsibility for the capital project managers as well as external service providers.

Travel

This position requires up to 10% travel.

Target Bonus

16%

New York Pay Range

$128,000 — $179,000 USD

Work Location

East Syracuse, NY

We are an Equal Employment Opportunity (“EEO”) Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!

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