Sr. Associate Mfg Systems

The Sr. Associate Mfg Systems provides technical engineering support in a highly automated manufacturing environment. This role supports system and equipment optimization strategies, upgrades, replacements, and modifications while ensuring maintenance and manufacturing systems remain compliant with corporate policies, industry standards, regulatory requirements, and FDA expectations.

This position operates in a 24/7 manufacturing environment and may be assigned to any of four shifts (A, B, C, or D), with availability required for 5:00 AM – 5:30 PM and/or 5:00 PM – 5:30 AM schedules.

Key Responsibilities

• Provide technical support for automated manufacturing systems and equipment.
• Support system optimization initiatives and continuous improvement efforts.
• Troubleshoot PLC systems (Rockwell platforms).
• Troubleshoot and adjust Vision Systems (Cognex and Systech).
• Support basic control systems hardware troubleshooting.
• Ensure automated systems operate reliably and efficiently in compliance with cGMP standards.
• Evaluate utility systems, instrumentation, calibration, electrical systems, and technical cleaning systems for regulatory compliance.
• Ensure all maintenance and automation activities comply with cGMP and FDA regulations.
• Assist during FDA and regulatory agency inspections.
• Support responses to regulatory observations and audit findings.
• Assist in maintaining internal audit programs to ensure continued inspection readiness.
• Coordinate technical support for maintenance teams related to automation, validation, compliance, electrical, and process issues.
• Ensure training programs, SOPs, and operational standards are consistent and compliant.
• Support investigations involving high purity water systems and environmental monitoring alerts/actions.
• Assist in testing and implementing updates to sanitization and maintenance procedures for process, utility, and cleanroom systems.
• Partner with Plant Engineering to implement engineering improvements and optimization programs.

Core Competencies

• Strong automation and equipment troubleshooting skills.
• Comprehensive understanding of validation protocol requirements.
• Analytical problem-solving capabilities.
• Ability to identify system gaps and implement effective corrective actions.
• Leadership and team-building skills.
• Strong facilitation and cross-functional collaboration abilities.
• Ability to manage and adapt to change in a dynamic manufacturing environment.
• Project management and planning skills.
• Scheduling and prioritization capabilities.
• Strong organizational skills and attention to detail.
• 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

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

Benefits:
Work Environment

• Automated manufacturing environment.
• Rotating 12-hour shifts (A, B, C, or D).
• Must be flexible to support both day and night operations.