Engineering Manager

* Lead a team of engineers to ensure projects are delivered on schedule, within budget, and in full compliance with industry regulations and safety standards.

* Equipment and facilities oversight: manage the installation, calibration, maintenance, and early qualification stages (FAT, SAT, IQ) of manufacturing equipment, HVAC systems, cleanrooms, and other critical infrastructure. Ensure all assets meet regulatory and industry requirements.

* Review and approve FAT and SAT documentation, and evaluate IQ documentation for accuracy and completeness.

* Capital projects: direct the planning, budgeting, and execution of major capital initiatives, including new facility construction, site expansions, and equipment acquisitions. Collaborate with cross-functional teams, contractors, and regulatory agencies to ensure projects are completed on time and within budget.

* Team leadership: provide technical guidance, mentorship, and support to engineers and technical personnel, establishing clear objectives, fostering collaboration, and maintaining a positive and productive work environment.

* Project management: oversee the planning, organization, and coordination of engineering projects from concept through completion, including budgeting, resource management, scheduling, and risk assessment.

* Ensure effective lifecycle management of equipment and facilities, utilizing reliability metrics to inform leadership and drive continuous improvement.

* Supervise the planning and execution of preventive maintenance and calibration programs.

* Manage external contractors for equipment validation, servicing, and maintenance activities.

* Technical expertise: apply knowledge of chemical engineering principles and pharmaceutical manufacturing processes to provide technical direction and ensure successful project delivery.

* Compliance and safety: maintain adherence to all relevant regulations, quality standards, and safety requirements. Stay current with industry best practices and implement strategies to mitigate operational risks.

* Cross-functional collaboration: work closely with R&D, manufacturing, quality assurance, and CMC teams to support product development and production activities.

* Develop and track key performance indicators (KPIs), including schedule adherence, project execution, and equipment reliability.