Calibration Lead

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 140,000 - 210,000; Full time

Job summary

Aveva Drug Delivery Systems in Tamarac, FL, seeks a Senior Engineering Leader to define and execute the site engineering strategy, drive capital projects, and lead a high‑performing maintenance team responsible for GMP manufacturing environments.

You will champion digital transformation, ensure FDA/EMA/DEA compliance, mentor engineering talent, and partner with Quality, Compliance, and Operations to sustain safety, quality, and continuous improvement across the site.

Qualifications

• Associate's or Bachelor's degree in engineering with pharma GMP context.
• 10+ years of progressive engineering leadership experience in pharmaceutical manufacturing, with at least 3 years executive.
• Proven experience managing engineering for pharmaceutical manufacturing; aseptic experience preferred.

Responsibilities

• Develop and execute the engineering strategy for the Tamarac site aligned with objectives and technology enhancements.
• Lead cross-functional initiatives to support capacity expansion, equipment modernization, and continuous improvement.
• Oversee selection, installation, and qualification of new manufacturing and packaging equipment.
• Provide engineering support for introduction and scale-up of new products from R&D to operations.
• Ensure FDA/EMA/DEA compliance and lead inspections readiness.

Skills

Engineering leadership

Strategic planning

Cross-functional leadership

Site operations

Continuous improvement

Project management

Digital transformation

Regulatory compliance

GMP knowledge

Education

Bachelor's degree in engineering

Associate's degree in engineering

Tools

Process equipment qualification

Job description

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.