Process Technology Specialist

We are seeking an experienced Process Technology Specialist to support manufacturing and packaging operations within a regulated medical device or pharmaceutical environment., * 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 Standard Operating Procedures (SOPs), protocols, reports, and other technical documentation
• Train manufacturing teams on SOPs and process requirements
• Support the selection and qualification of manufacturing equipment, facilities, and processes
• Ensure manufacturing processes meet applicable quality and regulatory requirements
• Partner cross-functionally with Operations, Engineering, Quality, Procurement, and other teams
• Balance production support, validation activities, compliance requirements, and project deadlines
• Participate in continuous improvement initiatives utilizing Lean, Six Sigma, or similar methodologies
• Provide hands-on technical support within the production environment

This position will focus on process validation, manufacturing process improvement, technical documentation, technology transfer, and new product introduction. The ideal candidate will have 3-5+ years of experience in medical device or pharmaceutical manufacturing and a strong engineering, scientific, or technical background. This is a hands-on role requiring strong technical writing skills and experience working within FDA and/or EU MDR-regulated environments., * Bachelor’s degree in Engineering, Science, Technology, or a related technical discipline, or equivalent relevant experience

• 3-5+ years of experience within medical device and/or pharmaceutical manufacturing
• Experience working within an FDA-regulated and/or EU MDR-regulated environment
• Hands-on experience with process validation and IQ/OQ/PQ
• Strong technical writing skills, including experience preparing validation protocols, qualification documentation, SOPs, and/or technical reports
• Experience troubleshooting manufacturing or production processes
• Strong analytical and problem-solving skills
• Ability to interpret process and manufacturing data and translate findings into actionable improvements
• Strong communication skills and demonstrated ability to work across Engineering, Quality, Operations, and other functions
• Strong organizational and project-management skills with the ability to manage multiple priorities

Preferred Qualifications

• Experience with medical device manufacturing processes and equipment
• Pharmaceutical manufacturing experience
• New Product Introduction (NPI) and/or technology transfer experience
• Experience with process or equipment qualification
• Familiarity with Lean, Six Sigma, or other continuous improvement methodologies
• Experience with Process Analytical Technology (PAT) or related manufacturing technologies
• Experience working in a smaller, hands-on manufacturing organization

Work Environment This position operates in a fast-paced manufacturing environment and requires close collaboration across Operations, Engineering, Quality, and other functional teams. The successful candidate will be comfortable taking ownership of projects, solving technical problems independently, and balancing production needs with validation, quality, and regulatory requirements. Candidates must have direct medical device and/or pharmaceutical industry experience to be considered.