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The Environmental Monitoring Team is responsible for the activities associated with the manufacture of safe, effective pharmaceuticals in accordance with company SOPs, and policies. The Environmental Monitoring Team works in concert with and assists the manufacturing department and plays a critical role in ensuring environmental control of the cleanroom. The EMT I position is primarily responsible for performing environmental monitoring activities including air, surface, and personnel monitoring within the cleanroom.
Schedule: Full-time (Benefits Eligible)
Location: Andelyn Corporate Center
1180 Arthur E. Adams Drive
Columbus, OH 43221
Principal Duties and Responsibilities:
- Conduct environmental monitoring activities including air (Viable and Non-viable), surface, and personnel inside the cleanrooms.
- Maintain accurate records of work performed in LIMS and Laboratory systems according to Good Documentation Practices, SOPs, and policies.
- Assist with data entry for analysis and trending.
- Record results and report deviation from specifications.
- Communicate any discrepancies or deviations to supervision/management upon discovery.
- Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
- Inputs data into the database and conducts trend analysis.
- Plan daily workload to meet requirements.
Knowledge, Skills, and Abilities required:
- Must possess High School Diploma/Equivalent, a background in the life sciences, biotechnology, or gene therapy industries preferred.
- No minimum experience.
- Experience in documentation preferred.
- Experience in highly regulated fields preferred.
- Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
- Must be computer literate in Microsoft Office (PowerPoint, Excel, Word)
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
- Must possess a client-focused mindset in daily tasks.
- Must possess prior experience.
- handling confidential information and the ability to maintain confidentiality.
Minimum Physical Requirements
- Occasionally Sitting
- Frequently Walking/Standing/Stooping
- Frequently Independently lift up to 25 pounds
- Frequently Talking on the phone or in person
- Frequently Typing on a computer keyboard
- Ability to wear cleanroom gowning and other PPE regularly.
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, 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 committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.
Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn. If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemption may be considered depending upon the specific job duties.