- Experience in SOP development and validation documentation (IQ/OQ/PQ).
- Knowledge of KPI analysis, maintenance metrics, and operational performance tracking.
- Understanding of engineering processes, maintenance operations, and manufacturing environments.
- Ability to read and interpret engineering drawings and technical specifications.
- Knowledge of project management principles.
- Experience with CMMS systems and digital tools.
- Strong analytical, organizational, and attention-to-detail skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency in office tools (advanced Excel, Word, PowerPoint) and project management software (MS Project, basic AutoCAD).
- Ability to work in teams, under pressure, and with multiple priorities.
- EDUCATION AND EXPERIENCE
- Bachelor’s degree in Industrial, Mechanical, or related Engineering field preferred.
- Minimum of 2 years of experience in document control, validation documentation, KPI management, or engineering support roles.
- Experience in nutraceutical, pharmaceutical, or regulated manufacturing environments preferred.
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| The Engineering Documentation Specialist is responsible for leading the development, control, and continuous improvement of technical documentation, validation programs, and performance monitoring systems within a cGMP-regulated nutraceutical manufacturing environment.
This role ensures that all engineering and maintenance documentation, including Standard Operating Procedures (SOPs) and validation documentation (IQ/OQ/PQ) is structured, compliant, and audit-ready in alignment with FDA regulations and internal quality systems.
Additionally, the position supports the definition, tracking, and analysis of key performance indicators (KPIs) related to operations, maintenance, and engineering projects, contributing to data-driven decision-making and continuous improvement initiatives.
The role provides direct support to the Technical Director across engineering projects, compliance initiatives, and operational performance optimization.
SOP Development and Document Control
- Lead the development, review, and standardization of SOPs related to equipment, processes, cleaning, and engineering operations.
- Ensure all documentation complies with cGMP, FDA requirements, and internal quality standards.
- Manage the full lifecycle of controlled documents including creation, revision, approval, distribution, and obsolescence.
- Maintain document traceability, version control, and audit readiness.
- Establish and improve documentation structures and templates to ensure consistency and compliance across departments.
Validation Documentation
- Lead the development and structuring of validation documentation including IQ, OQ, and PQ protocols.
- Prepare validation forms, templates, and final reports aligned with regulatory and internal requirements.
- Ensure all validation documentation is complete, accurate, and audit-ready.
- Collaborate with Engineering and Quality teams to align validation documentation with operational and compliance needs.
KPI Management, Performance & Continuous Improvement
- Support the definition, tracking, and analysis of KPIs related to:
- Maintenance performance (e.g., MTTR, MTBF, downtime, backlog)
- Operational efficiency
- Engineering project execution and timelines
- Develop reports, dashboards, and performance summaries to support decision-making.
- Analyze trends and identify opportunities for process improvement and efficiency optimization.
- Support continuous improvement initiatives aligned with engineering and maintenance strategies.
Engineering and Project Support
- Provide direct support to the Technical Director in engineering and capital projects.
- Support project planning, execution, and tracking aligned with PMI PMBOK methodologies.
- Develop process flow diagrams and technical documentation for engineering projects.
- Coordinate cross-functional activities with Production, Quality, Maintenance, and Procurement.
- Read and interpret 2D and 3D engineering drawings, layouts, and technical specifications.
- Support documentation for equipment installation, upgrades, and facility improvements.
- Assist in documenting engineering changes and technical updates.
Systems, CMMS, and Digital Tools
- Utilize CMMS and digital tools (e.g., Redzone, SharePoint, Microsoft Office) for documentation, tracking, and reporting.
- Maintain structured records for equipment, calibration, and engineering documentation.
- Support continuous improvement of digital documentation and performance tracking systems.
On-site position in Miramar, FL 33025
8:30am-5pm
$26 per hour
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