Director - Engineering and Maintenance

Syngene International Limited•Baltimore, MD

66d

About The Position

The Director, Engineering and Maintenance provides strategic and technical leadership across engineering, facilities, and maintenance functions. The role partners with senior leadership to drive capital projects, continuous improvement, and technology implementation to enhance equipment reliability, site capabilities, and operational performance. The Director is accountable for Facilities operations, including effective maintenance of utilities and infrastructure. The role also establishes engineering standards, supports new product introductions, and builds and develops a high-performing team. The Director oversees Facilities, Utilities, Maintenance, and Engineering functions and ensures alignment with site and business objectives. The role leads capital project planning and execution; maintains facilities, utilities, and equipment in accordance with industry best practices and regulatory requirements; and is accountable for Quality Systems within Engineering and Maintenance. It provides technical leadership across the design, implementation, and lifecycle management of equipment and systems, supports technology transfers, equipment upgrades, and facility expansions, and leads continuous improvement and reliability initiatives. The position manages departmental goals, budgets, resource allocation, and site capital planning; oversees contractors, consultants, and service providers; and serves as a departmental contact during audits and regulatory inspections. It also supports resolution of complex technical issues and promotes staff development through coaching, mentoring, and training. Syngene describes itself as an innovation-focused global discovery, development, and manufacturing organization. Safety is a core priority, with shared responsibility for following safety guidelines, procedures, and SOPs.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related field).
At least 10 years of experience in a biopharmaceutical or biotechnology environment, with leadership experience in engineering and/or facilities management.
Demonstrated career progression with increasing responsibility, leadership, and organizational impact.
Extensive knowledge of cGMP requirements, regulatory expectations, and compliance in a highly regulated environment.
Ability to lead and influence cross-functional teams and align engineering strategy with business objectives.
Experience in facility planning, asset lifecycle management, and infrastructure strategy.
Technical expertise in facility systems, utilities, and manufacturing equipment within cGMP environments.
Working knowledge of Quality Systems, including deviations, investigations, CAPAs, and change control processes.
Experience managing budgets, capital planning, and cost optimization.
Familiarity with digital and data-driven engineering tools, including predictive maintenance and performance monitoring systems.
Excellent written and verbal communication skills, with the ability to influence stakeholders at all organizational levels.
Ability to lead and develop teams, supporting employee growth and performance.
Ability to collaborate effectively with internal teams, contractors, suppliers, and regulatory agencies.
Experience in strategic planning, budgeting, forecasting, and resource allocation.
Proficiency in Microsoft Office applications and project management tools such as MS Project.
Demonstrated ability to manage multiple priorities in a dynamic, fast-paced environment.
Customer-focused and quality-driven, with a commitment to operational excellence and continuous improvement.

Nice To Haves

Prior experience with SAP or similar enterprise systems.

Responsibilities

Provide strategic and operational leadership for the Engineering and Maintenance organization.
Oversee Facilities, Utilities, Maintenance, and Engineering functions, aligning them with site and business objectives.
Oversee capital project planning and execution, including scope development, budgeting, scheduling, and implementation.
Ensure facilities, utilities, and equipment are maintained according to industry best practices and regulatory requirements.
Maintain accountability for Quality Systems within Engineering and Maintenance, including Deviations, CAPAs, SOP revisions, and Change Control.
Provide guidance and leadership to support compliance with health and safety policies and procedures.
Develop and execute departmental goals, strategies, and long-term plans aligned with organizational objectives.
Provide end-to-end technical leadership across design, implementation, and lifecycle management of equipment and systems.
Oversee and support technology transfers, equipment upgrades, and facility expansions.
Establish and maintain engineering standards, best practices, and governance across systems and processes.
Lead cross-functional teams to improve equipment reliability and operational efficiency and drive continuous improvement.
Serve as a departmental point of contact during internal and external audits and regulatory inspections.
Collaborate with senior leadership on business cases, resource plans, and engineering strategies.
Manage departmental budgets, resource allocation, and site capital planning.
Oversee external engineering contractors, consultants, and service providers.
Support troubleshooting and resolution of complex technical issues affecting manufacturing, facilities, and operations.
Promote staff professional development through coaching, mentoring, and training.