Calibration Lead

Job Details

Job Location: Tamarac, FL 33321

Position Type: Full Time

Job Shift: Swing

Strategic Leadership & Vision

• Develop and execute the engineering strategy for the Tamarac site aligned with siteobjectives, 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 allcalibration related activities incapital project activities at the Tamarac site, includingdesign, infrastructure upgrades, and equipment installations.
• Ensureaccurateproject scoping, budgeting, scheduling, and stakeholder alignment for new facility builds, renovations, and clean utility improvements.
• Guidethe engineering design for GMP manufacturing areas including sterile, non-sterile, and controlled substance environments.

Process, Equipment & Technology

• Oversee theselection, installation, and qualification of new manufacturing and packaging equipment, includingprocessequipment’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 thequalification and validation ofequipment,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

• Directmaintenanceand reliability programs for all site assets including process equipment, and packaging systems.
• Implement andoptimizepreventive 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 localandnational 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 andprovidecareer development opportunities.
• Recruits, trains, develop andmanage effectivelythe ongoing performance of their direct reports, which includes, but is not limited to:
• Ensuring all Job Descriptions for direct reports are periodically reviewed,signedand stored according to our job description processes.
• Reviewing and updating development plans for all direct reports, ensuring that all direct reports areproperly trainedand qualified according to our Training and Employee Qualification Enterprise Policy.
• Effectively managing performance for direct reports according to thePerformance Management Program,
• Oversee shift-wise engineering operations, ensuring smooth and uninterrupted production.
• Implement shift rotation plans to ensureoptimalresourceutilizationand compliance with labor laws.
• Attracting andretainingtalent based on our talent management framework.
• Scheduling regular one-on-one meetings, probationary performancereviewsand mid-year performance discussions.
• Providing regular coaching, feedback and recognition based on the expected behaviors, jobdescriptionand performance onobjectives; 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 workin accordance withour 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 engineeringand 10 years of pharmaceuticalGMPexperienceor aBatchelor'sdegreein engineeringand 7 yearsof pharmaceuticalGMPexperience.
• 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.