Sr. Associate Mfg Systems

The Sr. Associate, Manufacturing Systems provides technical engineering support for automation, equipment optimization, system upgrades, replacements, and modifications within a regulated manufacturing environment. This role ensures that maintenance operations, documentation, and system performance comply with corporate policies, industry standards, regulatory requirements, and FDA expectations.

The specialist supports cross‑functional teams, leads troubleshooting efforts, and contributes to continuous improvement initiatives across manufacturing systems.

RESPONSIBILITIES

• Evaluate utility systems, process maintenance activities, instrumentation, calibration, electrical systems, and technical cleaning systems to ensure compliance with industry, regulatory, and FDA standards.
• Ensure maintenance team training programs, SOPs, and operational standards are consistent and properly implemented.
• Provide technical support to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.
• Assist the maintenance team during FDA and other regulatory inspections; support responses to regulatory inquiries.
• Support investigations related to high‑purity water systems and environmental monitoring alert/action notifications.
• Assist in developing and maintaining an audit program for maintenance operations.
• Facilitate routine audits of documentation, activities, and operations to ensure a continued state of compliance.
• Support plant engineering in evaluating and implementing engineering improvements, policy updates, compliance enhancements, and optimization programs.
• Assist with testing proposed sanitization and maintenance procedure changes for process, utility, and clean room systems.
• Additional responsibilities may be assigned.
• SKILLS
• Strong understanding of validation protocol requirements
• Equipment‑specific technical expertise
• Analytical problem‑solving skills
• Project management and planning
• Scheduling and coordination
• Computer literacy and familiarity with automation systems
• Leadership and team‑building
• Strong verbal communication
• Technical writing and documentation
• Facilitation and cross‑functional collaboration
• Ability to manage change effectively
• Strong organizational skills and ability to follow assignments through completion
• Ability to support compliance investigations and regulatory expectations
• Ability to work independently and interact effectively across multiple levels

Requirements

• 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 (Standout Attributes)

• Experience with recipe entry in packaging equipment
• Automation assessment experience to determine correct recipe parameters
• Experience with Systech systems
• Strong understanding of decision‑making techniques
• Risk management experience