Aseptic Specialist

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. 

Role Summary

The purpose of this role is to observe and identify Aseptic Processing Area compliance deficiencies while partnering with Aseptic Operations to continuously improve aseptic behaviors and techniques in the execution of production related activities. In the process of observing deficiencies, this individual will coach and provide constructive feedback to aseptic personnel and management. Specialists will collect and evaluate information gained through the oversight process to develop and implement improvements to interactively correct and prevent compliance concerns across the aseptic manufacturing processes.

Role Responsibilities

•        Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite.

•        Provide immediate feedback during routine observation to develop and improve colleague techniques & capabilities.

•        Observe and identify opportunities related to aseptic processing microbiological science, microbiological control strategies, the environmental monitoring program and how each impact aseptic manufacturing processes.

•        Implement projects to improve aseptic process compliance to support effective and compliant process operations.

•        Evaluate aseptic processes during air flow visualization studies.

•        Act as an active quality observation area lead while observing aseptic technique and operations during media fill simulations.

•        Maintain and update proper documentation – SOPs, training records, batch records, check sheets, logbooks, etc.

•        Act as an active member of investigational activities as it relates to environmental & behavioral compliance events.

•        Aseptic qualifications are completed and maintained.

•        Must be self-motivated, able to work independently and have a problem-solving mindset.

Basic Qualifications

EDUCATION:

Bachelor’s degree in science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science)

EXPERIENCE:

Previous experience in aseptic manufacturing preferred but not required.

TECHNICAL SKILLS:

•        The capability to aseptically gown and maintain various levels of certification to enter and support the manufacturing areas.

•        The capability to focus attention on colleagues’ behaviors that in turn leads to higher-than-normal performance.

•        Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance / actions.

•        Demonstrated ability of strong self-awareness.

•        The ability to develop and execute qualification protocols related to area compliance.

•        The ability to expand knowledge of pharmaceutical manufacturing and regulatory compliance.

•        Ability to coach by providing constructive feedback combined with a willingness to develop and listen to colleague ideas.

•        Demonstrated aptitude to execute aseptic techniques to a high degree of proficiency.

•        Must be able to communicate, present, and work well with all facility departments.

•        Must be able to read and write, as well as follow written and oral operating instructions.

•        Must be capable of performing data entry into office applications and to use statistical software for data analysis.

•        Promote a positive team environment while performing all tasks in a safe manner.

•        Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal.

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