Director - Engineering and Maintenance

BioSpace; Baltimore (MD); On-site; USD 180,000 - 250,000; Full time

Job summary

Syngene seeks a Director of Engineering and Maintenance to lead engineering, facilities and maintenance, partnering with senior leaders to drive capital projects and continuous improvement. You will enhance equipment reliability, site capabilities and operations while ensuring compliant facilities and quality systems.

The role requires Bachelor’s in Engineering, biopharma/facilities leadership experience, and strong cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering required.
• Experience in biopharmaceutical/biotechnology environment with leadership in engineering/facilities.
• Extensive knowledge of cGMP and regulatory compliance in a highly regulated environment.
• Ability to lead cross-functional teams and align engineering strategy with business objectives.
• Experience with facility planning, asset lifecycle management, and infrastructure strategy.
• Technical expertise in facility systems, utilities and manufacturing equipment in cGMP environments.
• Familiarity with SAP or similar enterprise systems.

Responsibilities

• Provide strategic and operational leadership for Engineering and Maintenance.
• Oversee Facilities, Utilities, Maintenance, and Engineering functions to align with site goals.
• Lead capital project planning, budgeting, scheduling, and implementation.
• Ensure facilities, utilities, and equipment meet industry best practices and compliance.
• Own Quality Systems within Engineering and Maintenance (deviations, CAPAs, change control).
• Support health and safety policies and procedures.
• Develop and execute departmental goals and long-term plans.
• Provide end-to-end technical leadership across design, implementation, and lifecycle management.
• Oversee technology transfers, equipment upgrades, and facility expansions.
• Establish engineering standards, governance, and best practices across systems.
• Lead cross-functional teams to drive reliability and continuous improvement.
• Act as department liaison during audits and regulatory inspections.
• Collaborate with leadership on business cases and resource planning.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Strategic planning

Communication

Problem solving

Project management

Education

Bachelor's degree in Engineering

Tools

SAP

MS Project

Quality Systems (Deviations, CAPAs)

Job description

Job Title: Director - Engineering and Maintenance

Reporting to: VP - Site Head

Department: Engineering & Maintenance

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene' s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Job Summary

The Director, Engineering and Maintenance provides strategic and technical leadership across engineering, facilities, and maintenance functions. The Director 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, ensuring maintenance, utilities, and infrastructure are effectively maintained. Additionally, this role establishes engineering standards, supports new product introductions, and builds and develops high-performing team.

Primary Responsibilities

• Provide strategic and operational leadership for the Engineering and Maintenance organization
• Oversee Facilities, Utilities, Maintenance, and Engineering functions, ensuring alignment with site and business objectives
• Oversight of capital project planning and execution, including scope development, budgeting, scheduling, and implementation
• Ensure facilities, utilities, and equipment are maintained in accordance with industry best practices and regulatory requirements
• Accountable for all Quality Systems within the Engineering and Maintenance functions, including Deviations, CAPAs, SOP revisions (routine and biennial), and Change Control
• Provide guidance, leadership and directives to support and comply with all 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
• Provide oversight and support for technology transfers, equipment upgrades, and facility expansions
• Establish and maintain engineering standards, best practices, and governance across all systems and processes
• Lead cross-functional teams to drive equipment reliability, operational efficiency, and continuous improvement initiatives
• Serve as a departmental point of contact during internal and external audits and regulatory inspections
• Collaborate with senior leadership to develop 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 impacting manufacturing and facility systems and operations
• Promote professional development of staff through coaching, mentoring, and training

Education & Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related field) required
• Experienced in a biopharmaceutical or biotechnology environment, with leadership experience in engineering and/or facilities management
• Demonstrated career progression with increasing scope of 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
• Strong ability to collaborate effectively with internal teams, contractors, suppliers, and regulatory agencies
• Experience in strategic planning, budgeting, forecasting, and resource allocation
• Prior experience with SAP or similar enterprise systems preferred
• Proficiency in Microsoft Office applications and project management tools (e.g., 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

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.