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 equipments, 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.

Qualifications

- 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.