Sr. Manufacturing Systems Engineer 3546384 (Biotechnology Industry)

ProQuality Network; United States; Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

ProQuality Network is seeking a Sr. Associate Manufacturing Systems Engineer for a fully automated biotechnology manufacturing environment.

The role focuses on system optimization, upgrades, replacements, and modifications while ensuring maintenance complies with FDA regulations. This hands-on role requires strong troubleshooting, collaboration with maintenance and engineering teams, and support for a 24/7 operation across automation, utility, instrumentation, and maintenance systems.

Qualifikationen

• Bachelor’s degree in Engineering with at least 2 years of relevant experience; OR Associate’s degree with 6 years of engineering experience.
• Experience in FDA-regulated industries (preferred).
• Strong knowledge of PLC troubleshooting, particularly Rockwell systems.
• Experience troubleshooting Cognex Vision Systems.
• Knowledge of Systech Vision Systems troubleshooting and adjustments.
• Solid understanding of cGMP regulations.
• Knowledge of basic control systems hardware.

Aufgaben

• Evaluate and ensure utility systems, process maintenance, instrumentation, calibration, electrical systems, and technical cleaning systems comply with corporate, industry, regulatory, and FDA standards.
• Support system/equipment optimization strategies, upgrades, replacements, and modifications.
• Ensure maintenance training programs, standard operating procedures, and operational standards are consistent and compliant.
• Coordinate and provide technical support to the maintenance team on engineering, regulatory, compliance, validation, calibration, quality, microbial/environmental, and electrical matters.
• Support maintenance activities during FDA and other regulatory inspections. Provide technical expertise in responses to regulatory agencies.
• Assist in investigations related to high purity water systems and environmental monitoring alert/action notifications.

Kenntnisse

PLC troubleshooting

Cognex Vision Systems

Systech Vision Systems

cGMP compliance

FDA-regulated experience

Control systems hardware

Ausbildung

Bachelor’s degree in Engineering

Associate’s degree with 6 years of engineering experience

Tools

Rockwell Automation

Jobbeschreibung

Sr. Manufacturing Systems Engineer 3546384 (Biotechnology Industry)

Title: Sr. Associate Manufacturing Systems Engineer (Biotechnology Industry) – 3546384

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 Manufacturing Systems Engineer to support a fully automated biotechnological manufacturing environment. This role provides technical engineering support for system optimization, upgrades, replacements, and modifications, while ensuring maintenance operations remain compliant with corporate policies, industry standards, regulatory requirements, and FDA regulations.

This is a hands‑on role that requires strong troubleshooting expertise, collaboration with maintenance and engineering teams, and the ability to support a 24/7 manufacturing operation.

Summary

The Sr. Associate Manufacturing Systems Engineer will deliver technical engineering support across automation, utility, instrumentation, and maintenance systems. The role focuses on ensuring system reliability, compliance, and continuous improvement within a highly regulated biotechnology manufacturing environment.

Preferred Qualifications

• 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 PLC troubleshooting, particularly Rockwell systems.
• 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 and ensure utility systems, process maintenance, instrumentation, calibration, electrical systems, and technical cleaning systems comply with corporate, industry, regulatory, and FDA standards.
• Support system/equipment optimization strategies, upgrades, replacements, and modifications.
• Ensure maintenance training programs, standard operating procedures, and operational standards are consistent and compliant.
• Coordinate and provide technical support to the maintenance team on engineering, regulatory, compliance, validation, calibration, quality, microbial/environmental, and electrical matters.
• Support maintenance activities during FDA and other regulatory inspections. Provide technical expertise in responses to regulatory agencies.
• Assist in investigations related to high purity water systems and environmental monitoring alert/action notifications.
• Support the development and maintenance of internal audit programs to sustain a continuous state of compliance.
• Partner with plant engineering to evaluate and implement engineering improvements, compliance initiatives, and optimization programs.
• Assist in testing and implementing changes to sanitization and maintenance procedures for process, utility, and cleanroom systems.
• Perform other duties as assigned in support of manufacturing and engineering operations.

Education Requirements

• Bachelor’s degree in Engineering with at least 2 years of relevant experience; OR
• Associate’s degree with 6 years of engineering experience; OR

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 fast-paced environment.
• Comprehensive understanding of validation protocol requirements.
• Strong technical troubleshooting skills (equipment-specific expertise).
• Analytical problem-solving capabilities.
• Project management and planning skills.
• Scheduling and prioritization abilities.