Sr Plant Technologist (Aseptic Processes)

Fresenius Kabi USA • Wilson, NC

10d • $73,614 - $110,000

About The Position

This position will be responsible for supporting Aseptic Process Simulations (Media Fills) on traditional aseptic and isolator filling lines in the facility. The primary focus will be on protocol and final report generation and supporting media fill activities during manufacturing. Achieves these goals through aligning and optimizing local procedures with global processes, leading and directing project teams, coaching and providing technical support to manufacturing leaders and supervisors, and accounting for media fill status and releases against the published plan. Responsible for achieving goals, recording, and reporting key outputs to senior leadership. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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

Nice To Haves

• Minimum of 5+ years of aseptic manufacturing or environmental monitoring experience preferred.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees