Calibration Lead

Strategic Leadership & Vision 

• 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. 

Capital Projects & Facility Design 

• 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. 

Process, Equipment & Technology 

• 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. 

Regulatory & Quality 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. 

Maintenance, Utilities & Reliability 

• 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. 

Environmental Health & Safety (EH&S) 

• 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. 

Talent & Organizational Development 

• 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.   

• Works as a member of a team to achieve all outcomes.  

• Leads with a mindset that respects all cultural dimensions. 

• Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. 

• Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and  

• All other duties as assigned. 

Diploma/ Degree

• Associate's degree in engineering and 10 years of pharmaceutical GMP experience or a Batchelor's degree in engineering and 7 years of pharmaceutical GMP experience.  

• 10+ years of progressive engineering leadership experience in pharmaceutical manufacturing, with at least 3 years at an executive level. 

• Proven experience managing engineering for pharmaceutical manufacturing, aseptic experience preferred.