It’s an exciting time to join us!
The Andelyn Biosciences’ Contamination Control group is seeking a motivated individual to join our growing team as a Sr. Specialist - Cleaning and Disinfection.
The Sr. Specialist - Cleaning and Disinfection role is responsible for ensuring all operations related to the overall Cleaning and Disinfection 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 Facility Operations Manager and will work closely with a cross-functional team of Andelyn Biosciences staff.
Schedule: Full-time (Benefits Eligible)
Location: Central Campus
575 Children's Crossroads
Columbus, OH 43205
Under the guidance and direction of the Facility Operations Manager, essential functions of the Sr. Specialist - Cleaning and Disinfection include at a minimum:
- Identify gaps in facility processes that may increase contamination risk. Report possible risk management strategies and/or possible corrective measures to Facility Management.
- Participate in cleaning activities in the Cleanroom as required. Evaluate cleaning activities, contamination trends, identify and initiate process improvement initiatives for improving cleaning & disinfection outcomes.
- Report any deviations to procedures or non-adherence to contamination control best practices to the Facility Manager. Initiate and manage corrective and preventative action plans.
- Participate in the Andelyn Contamination Control Committee.
- Participate in quality event investigations and act as a liaison between the Facility, Manufacturing Operations, and Quality Assurance departments to execute the timely investigation of quality events.
- Author, revise, review, and manage Facility Cleaning & Disinfection documents, including but not limited to the following areas:
- Disinfectant Efficacy
- Cleaning Validation
- Facility and Equipment Cleaning / Disinfection Procedures
- Provide introductory, ongoing, and on-demand training for cleanroom operators.
- Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
- Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
- Frequent involvement in audits and customer relations.
Operate within the Quality Management System applicable to the manufacturing of phase-appropriate material in the CMF. - Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
- Demonstrate high level of integrity.
- Attention to detail in all job functions.
- Maintain positive attitude.
- Exercise crucial people skills.
- Other duties as assigned.
Knowledge, Skills, and Abilities Required
- Bachelor’s degree in a scientific related discipline.
- Minimum 4 years of experience in the pharmaceutical industry in GMP, Cleaning Validation, Aseptic Manufacturing, Operations, or contamination control-related department.
- 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
- Requires the ability to aseptically gown or wear other PPE on regular basis.
- Must be able to stand for extended periods.
- There are very minimal physical requirements.
- One needs to be able to lift up to 20-30 pounds (occasionally).
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
EOE M/F/Disability/Vet
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.