Sr. Associate Technical Support Engineer 3546403 (Biotechnology Industry)

Job Description

Job Description

Title: Sr. Associate Technical Engineering (Biotechnology Industry) – 3546403

Location: Open to Puerto Rico Residents

Shift: Must be available for any of the four shifts (A, B, C, or D)

Availability required: 5:00 a.m. – 5:30 p.m. and/or 5:00 p.m. – 5:30 a.m.

Contract Duration: Approximately 1 year

Open Positions: 1

Our client is seeking a Senior Associate Technical Engineering professional to support a biotechnology manufacturing operation. This position provides hands-on technical engineering support for system and equipment optimization, upgrades, replacements, and modifications, while ensuring maintenance operations remain compliant with corporate policies, industry standards, regulatory requirements, and FDA regulations.

This role requires strong troubleshooting capabilities, cross-functional collaboration, and the ability to operate effectively in a regulated, 24/7 manufacturing environment.

Summary

The Sr. Associate Technical Engineering professional will deliver technical support across utility systems, process maintenance, instrumentation, calibration, electrical systems, and cleanroom environments. The role focuses on equipment reliability, compliance, and continuous improvement initiatives to maintain operational excellence.

Preferred Qualifications

• Engineering degree preferred.
• Availability to work any assigned shift (A, B, C, or D), including 12-hour shifts (5:00 a.m. – 5:30 p.m. and/or 5:00 p.m. – 5:30 a.m.).
• Strong knowledge of mechanical equipment adjustment and troubleshooting.
• Experience troubleshooting PLC systems, particularly Rockwell platforms.
• Experience troubleshooting and adjusting Cognex Vision Systems.
• Knowledge of Systech Vision Systems troubleshooting and adjustments.
• Solid understanding of cGMP regulations.
• Knowledge of basic control systems hardware.
• Experience in FDA-regulated industries (preferred).

Key Responsibilities

• Evaluate utility systems, process maintenance, instrumentation, calibration, electrical systems, and technical cleaning systems to ensure compliance with corporate, industry, regulatory, and FDA standards.
• Support equipment and system optimization strategies, upgrades, replacements, and modifications.
• Ensure maintenance training programs, SOPs, and operational standards are aligned and consistently applied.
• Provide technical support to the maintenance team on engineering, compliance, calibration, validation, quality, microbial/environmental, and electrical matters.
• Support maintenance activities during FDA and other regulatory inspections, including technical responses to regulatory agencies.
• Assist with investigations related to high purity water systems and environmental monitoring alert/action notifications.
• Contribute to the development and maintenance of audit programs to ensure a sustained state of compliance.
• Partner with plant engineering to evaluate and implement engineering improvements, policy updates, compliance initiatives, and optimization programs.
• Assist in testing and implementing changes to sanitization and maintenance procedures for process, utility, and cleanroom systems.
• Perform additional duties as assigned in support of manufacturing operations.

Education Requirements

• Master’s degree; OR
• Bachelor’s degree with a minimum of 2 years of engineering experience; OR
• Associate’s degree with 6 years of engineering experience; OR
• High School Diploma/GED with 8 years of engineering experience.

Core Competencies

• Leadership and team-building skills.
• Strong verbal and written communication, including technical writing.
• Organizational and facilitation skills.
• Ability to manage change in a dynamic environment.
• Comprehensive understanding of validation protocol requirements.
• Equipment-specific technical troubleshooting expertise.
• Analytical problem-solving skills.
• Project management and planning capabilities.
• Scheduling and prioritization skills.
• Computer literacy.

If you meet the qualifications and are interested in contributing your technical expertise within a regulated biotechnology manufacturing environment, we encourage you to apply through the job description link and submit your updated resume for consideration.