Senior Calibration & Engineering Leader (GMP)

Aveva Drug Delivery Systems; Fort Lauderdale (FL); On-site; USD 180,000 - 260,000; Full time

Job summary

Aveva Drug Delivery Systems in Tamarac, FL seeks an experienced Senior Director of Engineering to shape and lead the site's engineering strategy, aligning with site objectives and regulatory requirements. You will guide cross-functional teams to support capacity expansion, equipment modernization, and continuous improvement across GMP facilities.

You will serve as the senior engineering leader, directing major technical decisions, overseeing calibration in capital projects, design of GMP

Qualifications

• Bachelor's degree in engineering with 7+ years pharmaceutical GMP experience.
• Associate degree in engineering with 10+ years pharmaceutical GMP experience.

Responsibilities

• Develop and execute the engineering strategy for the Tamarac site aligned with site objectives, operational excellence, and technology enhancements.
• Lead cross-functional initiatives at the site to support capacity expansion, equipment modernization, and continuous improvement.
• Serve as the senior engineering leader at the facility and provide directions on all major technical decisions.
• Lead all calibration related activities in capital project activities at the Tamarac site, including design, infrastructure upgrades, and equipment installations.
• Ensure accurate project scoping, budgeting, scheduling, and stakeholder alignment for new facility builds, renovations, and clean utility improvements.
• Guide the engineering design for GMP manufacturing areas including sterile, non-sterile, and controlled substance environments.
• Oversee the selection, installation, and qualification of new manufacturing and packaging equipment, including process equipment’s, and automated packaging lines.
• Provide engineering support for the introduction and scale-up of new products and technologies from R&D to commercial operations.
• Champion digital transformation and automation enhancements to support increased efficiency and compliance.
• Ensure all engineering activities at the Tamarac facility are compliant with FDA, EMA, DEA, and internal quality standards.
• Provide support for the qualification and validation of equipment, and facility systems.
• Maintain strict DEA compliance for facility design, storage, and access control of controlled substances.
• Ensure engineering readiness for audits and inspections and lead resolution of any related findings.
• Collaborate with Quality and Compliance teams during audits and inspections.
• Direct maintenance and reliability programs for all site assets including process equipment, and packaging systems.
• Implement and optimize preventive and predictive maintenance practices.
• Ensure high asset reliability and reduce downtime through robust engineering support and continuous improvement.
• Ensure engineering designs, equipment installations, and process changes incorporate EH&S risk assessments and mitigation plans.
• Collaborate with EHS teams to support compliance with local and national environmental and safety regulations.
• Ensure strict adherence to safety protocols and regulatory requirements in all engineering operations.
• Conduct routine safety audits, hazard assessments, and risk evaluations within BFS facilities.
• Promote a culture of safety through training, audits, and continuous improvement in workplace safety systems.
• Build, lead, and develop a high-performing engineering and maintenance team at the Tamarac facility.
• Foster a culture of innovation, accountability, and collaboration.
• Coordinate with the engineering team to troubleshoot and resolve technical issues swiftly during shifts.
• Mentor technical talent and provide career development opportunities.
• Recruits, trains, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
• Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our job description processes.
• Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Training and Employee Qualification Enterprise Policy.
• Effectively managing performance for direct reports according to the Performance Management Program,
• Oversee shift-wise engineering operations, ensuring smooth and uninterrupted production.
• Implement shift rotation plans to ensure optimal resource utilization and compliance with labor laws.
• Attracting and retaining talent based on our talent management framework.
• Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions.
• Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
• Responsible to ensure compliance of team members (direct reports) with the Business Ethics and Compliance Program, Quality procedures, Safety and Environment policies, and HR policies.

Skills

Engineering leadership

Cross-functional leadership

Strategic planning

Continuous improvement

Regulatory compliance

Education

Bachelor's degree in engineering

Associate's degree in engineering

Job description

Aveva Drug Delivery Systems in Tamarac, FL seeks an experienced Senior Director of Engineering to shape and lead the site's engineering strategy, aligning with site objectives and regulatory requirements. You will guide cross-functional teams to support capacity expansion, equipment modernization, and continuous improvement across GMP facilities.

You will serve as the senior engineering leader, directing major technical decisions, overseeing calibration in capital projects, design of GMP