Onsite Manufacturing Specialist - 6-Month Contract

Frey Consulting Group; Juncos (PR); On-site; USD 55,000 - 83,000; Full time

Job summary

Frey Consulting Group is seeking a Manufacturing Specialist to support manufacturing operations with minimal supervision. The selected candidate will contribute to the execution of manufacturing and quality systems, including Non-Conformances (NCs), process validation, manufacturing procedures, training, and New Product Introductions (NPI).

The ideal candidate will apply strong process and operational knowledge, analytical thinking, compliance awareness, and troubleshooting skills to support

Qualifications

• Master's degree + 2 years of Manufacturing Operations experience.
• Bachelor's degree + 4 years of Manufacturing Operations experience.
• Associate degree + 8 years of Manufacturing Operations experience.
• High School Diploma/GED + 10 years of Manufacturing Operations experience.
• Strong technical understanding of bioprocessing unit operations.
• Hands-on experience supporting GMP manufacturing operations.
• Working knowledge of regulatory requirements and participating in regulatory interactions.

Responsibilities

• Initiate, revise, review, and approve manufacturing procedures, ensuring documentation reflects current operations.
• Serve as the document owner for assigned manufacturing procedures and manage lifecycle.
• Assess process performance through floor observations and data analysis.
• Identify process improvements and evaluate/implement solutions.
• Provide technical troubleshooting support to manufacturing operations.
• Develop training materials and provide training on manufacturing processes.
• Support process monitoring parameter establishment and control limits.
• Collect/analyze process-monitoring data and evaluate deviations.
• Prepare and execute quarterly process monitoring reports.
• Participate in regulatory inspections, NPI, and equipment modifications.
• Assist with Change Control Review Board (CCRB) packages.
• Participate in cross-functional projects to improve performance and reliability.

Skills

Manufacturing operations

Document management

Hands-on troubleshooting

Analytical thinking

Regulatory compliance

Cross-functional collaboration

Technical writing

Process ownership

Education

Master's degree + 2 years Manufacturing Ops

Bachelor's degree + 4 years Manufacturing Ops

Associate degree + 8 years Manufacturing Ops

High School Diploma/GED + 10 years Manufacturing Ops

Job description

Frey Consulting Group is seeking a Manufacturing Specialist to support manufacturing operations with minimal supervision. The selected candidate will contribute to the execution of manufacturing and quality systems, including Non-Conformances (NCs), process validation, manufacturing procedures, training, and New Product Introductions (NPI).

The ideal candidate will apply strong process and operational knowledge, analytical thinking, compliance awareness, and troubleshooting skills to support