RIM Recruitment Professionalshttps://www.rimrp.com/wp-content/uploads/2022/08/rim-200x200-1.pnghttps://www.rimrp.comhttps://www.rimrp.comUSD115000.00YEARtrue
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.
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About Albany, GA
Explore exciting job opportunities in the vibrant Albany, Georgia area today! Known for its rich history, stunning architecture, and warm Southern hospitality, Albany offers a unique blend of urban amenities and outdoor adventures. With iconic landmarks like the Flint Riverquarium and the Thronateeska Heritage Center, delicious local cuisine, and a thriving arts scene including the Albany Museum of Art and the historic Albany Municipal Auditorium, there's something here for everyone. Whether you're interested in catching a game at the State Mutual Stadium or enjoying a peaceful day at Chehaw Park, Albany provides the perfect backdrop for personal and professional growth. Don't miss out on the chance to make your mark in this charming city!
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