Senior Manufacturing Systems Specialist

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 70,000 - 110,000; Part time

Job summary

BioPharma Consulting JAD Group is seeking a Sr. Associate, Manufacturing Systems to provide engineering support for automation, equipment optimization, and system upgrades within a regulated manufacturing environment.

The role involves working with cross-functional teams, leading troubleshooting efforts, and driving continuous improvement across manufacturing systems while ensuring compliance with FDA expectations and corporate standards.

Qualifications

• Requires deep knowledge of validation protocol requirements.
• Strong equipment-specific technical expertise.
• Analytical problem-solving skills are essential.
• Experience in project management and planning.
• Scheduling and coordination abilities are important.
• Familiarity with automation systems and documentation.
• Effective leadership and cross-functional collaboration.
• Excellent verbal communication and technical writing.
• Ability to manage change and ensure compliance.

Responsibilities

• Evaluate utility systems and maintenance activities against regulatory standards.
• Support training programs, SOPs, and operational standards.
• Provide technical support on engineering, regulatory, and quality issues.
• Assist during FDA inspections and regulatory inquiries.
• Support investigations related to environmental monitoring and water systems.
• Participate in auditing maintenance operations for compliance.
• Assist engineering in improvements and policy updates.
• Test proposed changes to sanitization and maintenance procedures.

Skills

Validation protocol

Equipment expertise

Analytical problem solving

Project management

Scheduling

Automation systems

Technical writing

Cross-functional collaboration

Communication

Education

Master’s degree

Bachelor’s degree + 2 years

Associate’s degree + 6 years

High School Diploma/GED + 8 years

Tools

Systech

Job description

BioPharma Consulting JAD Group is seeking a Sr. Associate, Manufacturing Systems to provide engineering support for automation, equipment optimization, and system upgrades within a regulated manufacturing environment.

The role involves working with cross-functional teams, leading troubleshooting efforts, and driving continuous improvement across manufacturing systems while ensuring compliance with FDA expectations and corporate standards.