Manufacturing Process & Validation Specialist

Integrated Services For Productivity & Validation, Inc; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc is seeking a highly experienced Manufacturing Operations professional in Juncos, Puerto Rico. The role focuses on initiating, revising, and approving manufacturing procedures, aligning with cGMP and regulatory requirements.

The position involves evaluating floor operations, implementing process improvements, and developing training materials. It includes participation in regulatory inspections, NPI activities, change control, and project

Qualifications

• Doctorate or Master’s + 2 years of Manufacturing Operations experience
• Bachelor’s + 4 years of Manufacturing Operations experience
• Associates + 8 years of Manufacturing Operations experience
• High school/GED + 10 years of Manufacturing Operations experience

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Ensure processes and procedures are aligned with cGMP requirements and/or other applicable regulations
• Identify, assess, and correct risks to ensure safety, quality, and efficiency of products manufactured
• Align Electronic Batch Records with current processes and assist in training
• Assist with generation and implementation of process validation protocols and reports
• Participate in regulatory inspections
• Participate in NPI process to assess documentation, materials, training, and equipment modifications
• Assess, prioritize, support, and provide implementation and project management support for process or equipment modification projects
• Own Change Control and ensure implementation within the established goal
• Assist manufacturing change owner on CCRB packages impacting the process
• Participate in noncommercial activity runs to collect and analyze process data
• Assist on assessment or implementation of special projects or initiatives

Job description

Integrated Services For Productivity & Validation, Inc is seeking a highly experienced Manufacturing Operations professional in Juncos, Puerto Rico. The role focuses on initiating, revising, and approving manufacturing procedures, aligning with cGMP and regulatory requirements.

The position involves evaluating floor operations, implementing process improvements, and developing training materials. It includes participation in regulatory inspections, NPI activities, change control, and project