Sr. Associate Mfg Systems

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

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

• 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

• 6-month contract with possible extension

• Administrative shift