Specialist 3 Operations Engineering

Katalyst Healthcares & Life Sciences - Athens, GA

Full-time - Mid Level

Athens, GA

Ambulatory Health Care Services

About the position

The Process Specialist is a technical expert responsible for providing support in operations engineering within the healthcare and life sciences sector. This role involves managing production schedules, ensuring compliance with quality standards, and implementing process improvements to enhance efficiency and reduce costs. The specialist will also act as a subject matter expert, guiding teams on deviations and investigations related to product quality.

Responsibilities

• Provide technical support for operations and production schedules.
• Facilitate the implementation of the production plan and take corrective actions for operational problems.
• Act as a subject matter expert (SME) on quality deviations and investigations.
• Study and recommend improvements for existing processes and systems to increase efficiency and quality.
• Track deviations and key process parameters, providing reports to management on trends and status.
• Ensure regulatory compliance and technical feasibility of proposed changes.
• Provide documentation support for SOP and batch record revisions.
• Assist with equipment startup and technical training as required.
• Support process and cleaning validation maintenance and verification.

Requirements

• 4-6 years of experience in a regulated manufacturing industry (chemical, pharmaceutical, medical device).
• Technical understanding of at least one processing area.
• Ability to operate SAP Production, COMET, and SUMMIT systems.
• Strong analytical skills to interpret technical documents and data.
• Effective written and verbal communication skills for regulatory documentation and presentations.
• Ability to manage multiple project priorities and work independently.

Nice-to-haves

• Experience with Minitab for data analysis.
• Familiarity with cGMPs and FDA regulations.
• Experience in technical writing and documentation.

Benefits

• Competitive salary range of $95.5K - $121K per year.
• Contract position with potential for extension.