Process Technology Specialist

Were seeking a Process Technology Specialist to provide technical and manufacturing support to our production and packaging operations. Youll focus on improving processes technologies and overall operational efficiency by authoring qualification documents driving process improvement initiatives supporting new product launches facilitating technology transfers and ensuring regulatory compliance through validation activities (IQ/OQ/PQ). In this role youll create execute and train teams on standard operating procedures while managing multiple competing priorities in a fast-paced results-driven environment.

• 3-5 years of experience in medical device or pharmaceutical manufacturing
• Engineering science or technology background
• Technical writing proficiency
• Knowledge of medical device regulations (US FDA or EU MDR)
• Proven validation experience

• Author qualification documents that support business and process improvement strategies
• Troubleshoot and resolve complex technical and production issues
• Identify areas of risk inefficiencies and opportunities for improvement through data analysis and testing
• Lead process validation activities including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ)
• Support technology transfer of new products and optimize existing manufacturing processes
• Manage multiple priorities including process improvements production schedules compliance and project timelines
• Interpret process data to identify solutions that enhance yield performance and compliance
• Collaborate cross-functionally with Operations Engineering Quality and Procurement teams to achieve site goals
• Ensure the selection of appropriate equipment facilities and processes while maintaining regulatory and quality standards
• Develop and maintain standard operating procedures (SOPs) and train teams on process execution
• Contribute to the implementation of continuous improvement methodologies (Lean Six Sigma)

• Bachelors degree in a technical scientific or related discipline or equivalent experience
• Minimum 3-5 years of experience in a regulated manufacturing environment (pharmaceutical medical device or similar)
• Proven experience in process validation and troubleshooting technical issues
• Strong analytical and problem-solving skills with the ability to interpret complex data
• Excellent communication and interpersonal skills with the ability to work cross-functionally and adapt to a team-oriented environment
• Highly organized detail-oriented and action-driven with strong project management capabilities
• Comfortable working in smaller teams where flexibility and self-driven execution are essential
• Proficiency in relevant software tools and systems used in manufacturing environments

• Familiarity with continuous improvement methodologies (Lean Six Sigma)
• Experience with process analytical technologies

This position operates in a dynamic production environment requiring collaboration across multiple teams and functions. Success involves balancing technical problem-solving process optimization and regulatory compliance within a fast-paced results-driven setting.

• Location: Albany GA
• Work Type: Onsite
• Position Level: Individual Contributor
• Salary Range: $95000$115000
• Bonus: 10% annual bonus (eligible)

• Medical dental and vision coverage with 100% of premiums covered for employees and dependents
• 401(k) retirement savings plan with 100% company match on the first 4% of contributions (begins 90 days after hire)
• 7% safe harbor retirement contribution
• Relocation assistance available on a case-by-case basis