Job Description

Process Technology Specialist

Must Have Requirements:

1. 3-5+ years of Medical Device/Pharma experience
2. Engineering, Science and Technology background
3. Validation
4. Technical writing of course
5. Med Device Regulations experience (US FDA or EU MDR)

Position Summary:
The Process Technology Specialist provides technical and manufacturing support to production and packaging operations. The role focuses on improving processes, technologies, and overall operational efficiency. Success in this role is achieved through authoring qualification documents, driving process improvement initiatives, supporting new product launches, facilitating technology transfers, and ensuring compliance through validation activities (IQ/OQ/PQ). The Specialist will also create, execute, and train teams on standard operating procedures (SOPs).

Key Responsibilities:

• Develops and authors qualification documents to support business and process improvement strategies.
• Troubleshoots and resolves complex technical and production issues.
• Identifies areas of risk, inefficiencies, and opportunities for improvement through data analysis and testing.
• Leads process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Supports the technology transfer of new products and optimizes existing manufacturing processes.
• Manages multiple priorities, including process improvements, production schedules, compliance, and project timelines.
• Interprets process data to identify solutions that enhance yield, performance, and compliance.
• Collaborates cross-functionally with Operations, Engineering, Quality, and Procurement teams to achieve site goals.
• Ensures the selection of appropriate equipment, facilities, and processes, while maintaining regulatory and quality standards.
• Develops and maintains standard operating procedures (SOPs) and trains teams on process execution.
• Contributes to the implementation of continuous improvement methodologies (e.g., Lean, Six Sigma).

Qualifications and Skills:

• Bachelor’s Degree in a technical, scientific, or related discipline, or equivalent experience.
• Minimum of 3-5 years of experience in a regulated manufacturing environment (pharmaceutical, medical device, or similar).
• Proven experience in process validation and troubleshooting technical issues.
• Familiarity with continuous improvement methodologies (e.g., Lean, Six Sigma) and process analytical technologies is a plus.
• 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.

About the Environment:
The position operates in a dynamic production environment, requiring collaboration across multiple teams and functions. Success in this role involves balancing technical problem-solving, process optimization, and compliance within a fast-paced and results-driven setting.