Facility Specialist – Operations/Status Change
It’s an exciting time to join us!
The Andelyn Biosciences’ Facilities group is seeking a motivated individual to join our growing team as an Facility Operations Specialist.
The Facility Operations Specialist role is responsible for ensuring that all operations related to the overall Contamination Control Strategy in the Clinical Manufacturing Facility are in compliance with Good Manufacturing Practices (cGMP) regulations and FDA and EU contamination control expectations. This position reports to the Contamination Control Manager and will work closely with a cross functional team of Andelyn Biosciences staff.
Schedule: Full-time (Benefits Eligible)
700 Children's Drive
Columbus, OH 43205
Under the guidance and direction of Facility Management, essential functions of the Facility Operations Specialist include at a minimum:
1. Maintain compliance with applicable regulatory requirements for the manufacture of sterile drug products.
2. Identify gaps in facility operation processes which may increase contamination risk. Report possible issues to Facility Management.
3. Report any deviations to procedures or non-adherence to contamination control best practice to Facility Management. Participate in corrective and preventative action plans.
4. Monitor in-use inventory of critical cleanroom PPE and/or cleaning / disinfection supplies, coordinate supply ordering / stocking.
5. Participate cross-functionally with the Facility, Manufacturing Operations, and Quality Assurance departments to execute the timely investigation of quality events.
6. Execute and coordinate cleanroom status change activities to ensure all critical tasks are executed at the conclusion of manufacturing campaigns / lots and prior to initiation of subsequent manufacturing activities.
7. Assist the Quality Assurance department with product disposition by providing any necessary facility operation documentation and / or reporting.
8. Compile and review facility documentation for accuracy and completion. File as appropriate.
9. Provide introductory, on-going, and on-demand training for cleanroom operators.
10. Exercise crucial people skills
11. Cultivate a diverse and collaborative team environment
12. Utilize clear and concise communication to deliver high productivity and contribution to the success of department goals
13. Attention to detail in all job functions
14. Other duties as assigned.
Knowledge, Skills, and Education: Bachelor’s degree in scientific related discipline. Experience in the pharmaceutical industry in Facility Operations, Aseptic Manufacturing Operations, or contamination control-related department preferred. Excellent communication skills, both written and verbal, in combination with strong interpersonal skills and demonstrated technical writing skills. Ability to work in a fast-paced environment and prioritize workload. Proficiency with applicable software (Trackwise, Microsoft Office, etc.) preferred
Minimum Physical Requirements: Sitting (Constantly) Talking on the phone/in person (Constantly) Typing on a computer keyboard (Constantly) Standing/walking (Occasionally) Lifting 45 lbs or greater (Frequently)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.
Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law. As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment. Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.