Senior Pharma Manufacturing Systems Specialist

FITS LLC; Juncos (PR); Hybrid; USD 55,000 - 85,000; Full time

Job summary

FITS LLC in Juncos, Puerto Rico, is seeking an engineer to support pharmaceutical and regulated industry operations. The role covers multi-department collaboration, equipment maintenance, regulatory compliance, and continuous improvement in process and cleaning procedures.

You will evaluate utility systems, calibration and electrical systems, manage training, and assist with inspections by FDA and other agencies. Bilingual English/Spanish, PM skills, and a degree are required.

Qualifications

• Bachelor's Degree with two years of experience as an Engineer in pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills required.
• Shift: Administrative and according to business needs.
• Experience in recipe entry on packaging equipment, validation protocol requirements, Systech/parameters, and automation assessments.

Responsibilities

• Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with industry, regulatory, and FDA standards.
• Ensure maintenance team training programs, standard operating procedures, and equipment standards are consistent.
• Coordinate technical support on engineering, regulatory, compliance, calibration, quality, environmental, and validation issues.
• Assist maintenance team during FDA and regulatory inspections and provide technical support.
• Assist with investigations of high purity water systems and environmental monitoring alerts/actions.
• Develop and maintain an audit program for the maintenance team and facilitate routine audits.
• Assist plant engineering in evaluating and implementing engineering improvements and policy changes.

Skills

Bilingual (English & Spanish)

Project Management

Regulatory industry experience

Shift: Administrative

Experience in packaging equipment

Validation protocol requirements

Systech Systems

Automation assessments

Education

Bachelor's Degree

Tools

Systech Systems

Job description

FITS LLC in Juncos, Puerto Rico, is seeking an engineer to support pharmaceutical and regulated industry operations. The role covers multi-department collaboration, equipment maintenance, regulatory compliance, and continuous improvement in process and cleaning procedures.

You will evaluate utility systems, calibration and electrical systems, manage training, and assist with inspections by FDA and other agencies. Bilingual English/Spanish, PM skills, and a degree are required.