Process Technology Specialist: Validation & NPI

Silicon Valley Recruiting LLC; Albany (GA); On-site; USD 70,000 - 100,000; Full time

Job summary

Silicon Valley Recruiting LLC is assisting Albany, GA area employers in finding a Process Technology Specialist for a hands-on role in regulated medical device and pharmaceutical manufacturing.

The ideal candidate will lead validation, tech transfer, and process improvements, with 3-5+ years experience, strong technical writing, and proven ability to work across Operations, Engineering, and Quality. Relocation provided if needed; onsite at a fast-paced facility.

Qualifications

• Bachelor's degree in Engineering, Science, Technology, or related technical discipline.
• 3-5+ years of experience in medical device and/or pharmaceutical manufacturing.
• Experience in FDA- and/or EU MDR-regulated environments.
• Hands-on experience with process validation and IQ/OQ/PQ.
• Strong technical writing and documentation experience.

Responsibilities

• Develop and author qualification and validation documentation for manufacturing processes and equipment.
• Lead and support IQ/OQ/PQ validation activities.
• Troubleshoot complex manufacturing, equipment, and production issues.
• Analyze process data to identify risks, inefficiencies, and opportunities to improve yield, quality, and performance.
• Support technology transfer and new product introduction (NPI) activities.
• Optimize existing manufacturing and packaging processes.
• Develop, revise, and maintain SOPs, protocols, reports, and other technical documentation.
• Train manufacturing teams on SOPs and process requirements.
• Support selection and qualification of manufacturing equipment, facilities, and processes.
• Ensure manufacturing processes meet quality and regulatory requirements.
• Partner cross-functionally with Operations, Engineering, Quality, Procurement, and others.
• Balance production support, validation activities, compliance, and deadlines.
• Participate in continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Provide hands-on technical support within production.

Skills

Tech writing

Process validation

Data analysis

Cross-functional work

Problem solving

Education

Bachelor's degree in Engineering/Science/Tech

Tools

Documentation tools

Job description

Silicon Valley Recruiting LLC is assisting Albany, GA area employers in finding a Process Technology Specialist for a hands-on role in regulated medical device and pharmaceutical manufacturing.

The ideal candidate will lead validation, tech transfer, and process improvements, with 3-5+ years experience, strong technical writing, and proven ability to work across Operations, Engineering, and Quality. Relocation provided if needed; onsite at a fast-paced facility.