Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as an Aseptic Fill/Finish Manager located in Plantation, FL.
Job Type: Full-time
Job Description:
We are seeking a highly skilled and experienced Manager for Aseptic Fill Finish Manufacturing to oversee all aspects of our Fill Finish Manufacturing functions. The successful candidate will have hands-on responsibility for operational management and planning of Fill Finish activities. This role requires a strong understanding of GMP aseptic manufacturing processes and the ability to troubleshoot and execute these processes efficiently.
Key Responsibilities:
- Develop and maintain Subject Matter Expert (SME)-level understanding of GMP aseptic manufacturing processes.
- Expertly execute and troubleshoot automated and semi-automated fill-finish equipment.
- Maintain the Aseptic Fill and Finish training matrix, ensuring staff compliance.
- Provide operational support, including material stocking, kit preparation, and equipment maintenance.
- Review documents, including Batch Records and Logbooks, and support documentation needs.
- Lead Change Controls of SOPs, Batch Records, etc., as required.
- Contribute to interdepartmental projects and technical transfers.
- Mentor staff and identify training needs to ensure continuous improvement.
- Work independently and in a team environment, adhering to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
- Lead departmental projects and escalate issues to management as needed.
- Maintain compliance with regulatory requirements and ensure accurate data recording.
Required Qualifications:
- Bachelor's degree or some post-secondary education.
- Strong technical knowledge of automated aseptic processing in cleanroom environments.
- Experience in aseptic manufacturing processes for sterile biologic drug substances and products.
- Proficiency in Microsoft Excel, Word, and Outlook.
- Ability to perform arithmetic and algebraic calculations accurately.
- Proven leadership skills with experience in coaching, mentoring, and developing staff.
- Excellent communication skills and the ability to manage change effectively.
Preferred Qualifications:
- Minimum 2+ years of experience in pharma/biopharma GMP sterile manufacturing operations.
- Familiarity with GXP best practices and FDA regulations.
- Proactive, results-oriented self-starter with experience in complex manufacturing environments.
Visual Inspection Program:
- Must be able to pass a Vision Exam.
- Must not be color blind and must have 20/20 vision (can be corrected).
Interacts with:
- All Cross-Functional Departments
APPLY NOW FOR IMMEDIATE CONSIDERATION!!
