Sr Associate Tech Engineering

The Sr. Associate Technical Engineering provides technical engineering support for system and equipment optimization, upgrades, replacements, and modifications across manufacturing operations. This role ensures maintenance activities and engineering systems remain compliant with corporate policies, industry standards, regulatory requirements, and FDA expectations. The position supports a 24/7 manufacturing environment and may be assigned to any of four shifts (A, B, C, or D), including availability from 5:00 AM – 5:30 PM and/or 5:00 PM – 5:30 AM.

Key Responsibilities

• Provide engineering support for system/equipment optimization strategies and continuous improvement initiatives.
• Evaluate utility systems, instrumentation, calibration, electrical systems, process maintenance, and technical cleaning systems for compliance with regulatory and industry standards.
• Support troubleshooting and adjustment of mechanical equipment.
• Assist in PLC troubleshooting (Rockwell platforms).
• Support Vision System troubleshooting and adjustments (Cognex and Systech).
• Assist with control systems hardware troubleshooting.
• Ensure maintenance team training programs, SOPs, and operational standards are consistent and compliant.
• Support maintenance operations to ensure alignment with cGMP and FDA standards.
• Assist during FDA and regulatory agency inspections and support responses to observations.
• Support development and execution of internal audit programs to maintain inspection readiness.
• Assist with investigations related to high purity water systems and environmental monitoring alert/action notifications.
• Provide technical support for microbial, environmental, validation, and calibration-related issues.
• Support evaluation and testing of sanitization and maintenance procedure updates for process, utility, and cleanroom systems.
• Coordinate technical support for maintenance teams across engineering, compliance, validation, quality, and process-related matters.
• Partner with Plant Engineering to evaluate and implement engineering improvements and optimization programs.
• Assist with policy updates and compliance enhancement initiatives.

Core Competencies

• Strong technical troubleshooting skills (equipment-specific).
• Comprehensive understanding of validation protocol requirements.
• Analytical problem-solving capabilities.
• Ability to assess compliance gaps and implement corrective actions.
• Leadership and team-building skills.
• Ability to facilitate discussions and coordinate cross-functional teams.
• Effective at managing and adapting to change.
• Project management and planning capabilities.
• Scheduling and prioritization skills.
• Strong organizational abilities and follow-through.
• Strong verbal communication skills.
• Strong written communication and technical writing skills.
• Computer literacy (Microsoft Office and related systems).

Requirements:
Education & Experience

• Master’s Degree OR
• Bachelor’s Degree + 2 years of Engineering experience OR
• Associate’s Degree + 6 years of Engineering experience OR
• High School Diploma/GED + 8 years of Engineering experience

Preferred Qualifications

• Knowledge of Mechanical Equipment Adjustment and Troubleshooting.
• PLC troubleshooting experience (Rockwell).
• Vision Systems troubleshooting/adjustment experience (Cognex, Systech).
• Strong knowledge of cGMP requirements.
• Experience in FDA-regulated industries.
• Knowledge of basic control systems hardware.

Benefits:
Work Environment & Schedule

• Manufacturing/plant environment.
• Must be flexible to support rotating shifts (A, B, C, or D).
• Availability required for 12-hour shift structures (day and/or night shifts).
• 1- year contract