Sr Plant Technologist (Aseptic Processes)

• Training and Education: Provide training, mentoring, and facilitation to employees and leaders across the filling manufacturing lines on media fill requirements and best practices. Develop, prepare, and maintain training materials as required to support these activities.
• Support the Media Fill Program: Analyze executed batch records for intervention frequency by line and matrix into the yearly plan to optimize the media fill schedule. Coordinate with Technical Transfer / Validation for additional media fill requirements and integrate into the yearly plan. Lead continuous improvement projects for the media fill program.
• Technical Writing: Author and coordinate timely review and approval of all media fill protocols. Analyze media fill results, author, and coordinate timely review and approval of all media fill final reports.
• Execution Oversight: Ensure physical oversight for all media fill executions by coordinating compliance oversight across multiple departments by coordinating with Manufacturing Quality Assurance, Aseptic Mentors, and Filling Supervisors. Ensure all operators are participating in media fills as required by SOP by coordinating with manufacturing and training leadership.
• Health, Safety, Environment, Energy & Quality: All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

• Bachelor's degree in a technical discipline, preferably Microbiology, Industrial or Manufacturing Engineering, or equivalent technical experience required.
• Advanced training or experience in cGMP, GLP, and ISO requirements.
• Excellent verbal and written communication skills, negotiation, and problem resolution skills.
• Must be organized, detailed, and have the ability to handle multiple tasks at once and redirect focus based on company's needs.
• Must be able to function independently with minimal supervision.
• Minimum of 5+ years of aseptic manufacturing or environmental monitoring experience preferred.

Must be able to manage situations of responsibility without authority by leading and coaching other Team Leaders to drive their projects forward.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.