Process Technology Specialist
About The Position
We are seeking an experienced Process Technology Specialist to support manufacturing and packaging operations within a regulated medical device or pharmaceutical 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.
Requirements
- 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
- Direct medical device and/or pharmaceutical industry experience
Nice To Haves
- 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
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 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
Benefits
- Relocation will be provided if the selected candidate lives outside of the Albany, GA., area.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
