Specialist Tech Engineering

Job DescriptionJob Description

The Specialist, Technical Engineering will provide advanced technical engineering support for all system and equipment optimization strategies, upgrades, replacements, and modifications. This role ensures that maintenance team operations are carried out in compliance with corporate policies, industry standards, regulatory standards, and FDA requirements. The Specialist will serve as a key resource in supporting compliance, troubleshooting, and continuous improvement across multiple systems.

Key Responsibilities

• Ensure utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems are maintained in compliance with industry and FDA standards.
• Maintain and align maintenance team training programs, SOPs, and operational standards.
• Provide technical support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, validation, electrical, and process maintenance issues.
• Support the maintenance team during FDA and regulatory inspections, including preparing responses and corrective actions.
• Respond to high purity water system and environmental monitoring alerts/actions; lead investigations and resolutions.
• Develop, implement, and maintain an internal audit program for maintenance activities, documentation, and operations to ensure ongoing compliance.
• Partner with Plant Engineering to evaluate and implement engineering improvements, compliance initiatives, and optimization programs.
• Evaluate and propose changes to sanitization and maintenance procedures.
• Recommend system modifications for process, utility, and clean room systems to the Plant Engineering Group.

Core Competencies & Skills

• Leadership and team building
• Strong verbal and written communication, including technical writing
• Organizational skills and ability to manage multiple priorities
• Facilitation and change management skills
• Comprehensive understanding of validation protocol requirements
• Technical equipment knowledge and troubleshooting expertise
• Analytical problem-solving
• Project management and planning
• Scheduling and coordination
• Computer literacy

Requirements

Education & Experience Requirements

• Doctorate degree in Engineering, or
• Master’s degree in Engineering with 3 years of experience, or
• Bachelor’s degree in Engineering with 5 years of experience, or
• Associate’s degree with 10 years of Engineering experience, or
• High school diploma/GED with 12 years of Engineering experience.

Qualifications

• Experience with MAXIMO (data entry, data sheets, job plans, MMP packages creation)
• Knowledge of drawings and technical documentation
• Highly organized, detail-oriented, and proactive in identifying improvements

Benefits

• Administrative Shift
• 6-month contract with possible extension