Specialist Tech Engineering

Juncos, PR
Autónomo
Tiempo completo

Hace 2 días

Job 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.

Preferred 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

BioPharma Consulting JAD Group

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