Senior Aseptic / Final Fills Specialist
The incumbent will be a member of the Manufacturing Group, responsible for aseptic Filling operations to include Filling, Equipment preparations, Environmental Monitoring activities within the Class A/B areas, Loading/Unloading vials, stoppers, and cleaning activities. The individual will be responsible for working through complex filling issues immediately. This individual may be required to work on validation projects and new filling tasks which require qualification.
The main responsibilities will include but not limited to follows:
- Provide hands-on direction for Aseptic/Sterile Fill Finish cGMP manufacturing activities.
- This position requires extensive technical expertise in Aseptic Techniques and Filling. Oversee and schedule compounding and filling operations within cGMP guidelines for Drug Products.
- Experience with Flexicon Automated Fill unit a huge plus.
- Perform Environmental Monitoring for Grade A/B during product fills to EU guidelines.
- Equipment and tubing Assembly preparation related to the filling operation.
- Troubleshoot complex drug product fill problems. Leads the formulation/fill finish tasks. Identify issues and propose adequate solutions.
- Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, and other technical documents as it relates to the Fill Finish Operation.
- Oversee the inventory of components and spare parts for the fill machine
- Maintain and foster an environment of safety in the laboratory by becoming trained in and adhering to the safety policies of the laboratory.
- Comply with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.
- Foster team building and provide the necessary training to other staff members as required
- Ensure that all processing equipment and instruments are identified, and maintained as per internal approved procedures.
- Communicate and suggest regular process improvement to management
- Work effectively with QA/QC, manufacturing, facilities and other support staff personnel.
- Cross train as needed with the manufacturing team.
Knowledge and Experience Required:
- A minimum of 5 year experience is required with Aseptic/Sterile Fill Finish tasks.
- BS degree in science field, experience may be considered in lieu of a degree.
- Experience in a cGMP environment is required.
- The candidate must have strong and effective interpersonal skills (both written and oral) and ability to communicate effectively with QA/QC, manufacturing, facilities and other support staff.
- Task and Team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multi-task is essential