Engineering Technical Specialist

Job DescriptionJob Description

Title: Engineering Technical Specialist (3420326)

Location: Hybrid/Remote Administrative Shift (Open to Puerto Rico )

Positions Available: 1

Duration: Approximately 3 months

Summary

Our client, a leading organization in the pharmaceutical and biotechnology industry, is seeking an Engineering Technical Specialist to provide technical engineering support for system and equipment optimization strategies, upgrades, replacements, and modifications. This role ensures that maintenance operations and activities are performed in full compliance with corporate policies, industry standards, and regulatory requirements, including FDA regulations.

Qualifications

• Strong organizational skills with attention to detail
• Experience with MAXIMO data entry and job plan creation
• Proficiency in generating data sheets and MMP (Maintenance Master Plan) packages
• Familiarity with engineering drawings and documentation

Key Responsibilities

• Ensure compliance of utility systems, process maintenance, instrumentation, calibration, electrical systems, and technical cleaning systems with applicable industry standards, regulatory requirements, and FDA standards.
• Oversee the consistency of maintenance team training programs, standard operating procedures (SOPs), and equipment/system operational standards.
• Provide technical support to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.
• Support the maintenance team during FDA and other regulatory agency inspections, including preparation, participation, and response activities.
• Assist in investigations related to high-purity water systems, environmental monitoring alerts, and action-level notifications.
• Support the development, implementation, and maintenance of an internal audit program for the maintenance team; facilitate routine audits of activities, documentation, and operations to ensure a continued state of compliance.
• Collaborate with plant engineering to evaluate and implement engineering improvements, policy changes, compliance enhancements, and optimization initiatives.
• Assess and improve sanitization and maintenance procedures to align with best practices and regulatory expectations.
• Propose process modifications, utility system improvements, and cleanroom system upgrades to the Plant Engineering Group and Department Manager.

Education & Experience Requirements

• Doctorate degree in Engineering, or
• Masters degree with 3 years of engineering experience, or
• Bachelors degree with 5 years of engineering experience, or
• Associates degree with 10 years of engineering experience, or
• High School Diploma/GED with 12 years of engineering experience

Core Competencies & Skills

• Leadership and team-building abilities
• Strong verbal and written communication, including technical writing
• Excellent organizational and facilitation skills
• Ability to manage and adapt to change effectively
• Comprehensive understanding of validation protocol requirements
• Equipment-specific technical knowledge
• Analytical and problem-solving skills
• Project management, planning, and scheduling expertise
• Proficiency in computer literacy and technical applications

How to Apply

Interested candidates are encouraged to submit an updated resume inside the job description link for evaluation and consideration.