Manufacturing Process Excellence Specialist

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico is seeking a Manufacturing Operations professional with advanced degree and significant experience to own and improve manufacturing procedures and drive process performance.

You will assess floor operations, ensure regulatory alignment, and support change control, process validation, and NPI initiatives, while training others on technical aspects. Admin shift 8am-5pm; OT may be required.

Qualifications

• Doctorate or Master's degree with 2+ years in Manufacturing Operations.
• Bachelor's degree with 4+ years in Manufacturing Operations.
• Associates degree with 8+ years in Manufacturing Operations.
• High school or GED with 10+ years in Manufacturing Operations.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as a document owner.
• Assess process performance and implement improvement opportunities.
• Assist in training materials and provide training on scientific/technical aspects.
• Ensure processes comply with cGMP and applicable regulations.
• Identify and mitigate risks to safety, quality, and efficiency of products.
• Align Electronic Batch Record with current process and assist training.
• Assist with process validation protocols and reports.
• Participate in regulatory inspections.
• Support NPI requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, and support process or equipment modification projects.
• Own Change Control and ensure timely implementation.
• Assist CCRB packages impacting the process.
• Participate in noncommercial runs to collect/analyze process data.
• Contribute to special projects or initiatives.

Education

PhD or MSc + 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

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico is seeking a Manufacturing Operations professional with advanced degree and significant experience to own and improve manufacturing procedures and drive process performance.

You will assess floor operations, ensure regulatory alignment, and support change control, process validation, and NPI initiatives, while training others on technical aspects. Admin shift 8am-5pm; OT may be required.