Title: Technical Writer - Manufacturing Specialist
Pay Rate: $21/hr  
Location:  Harmons MD 
Schedule: Monday through Friday 8-5 onsite
Duration: 12 months 
Start:  ASAP 

Education: 
Bachelor’s degree in a science or engineering field 

Requirements: 
-  4+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
-  Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
- 3+ years of experience in process deviation investigations and remediation

Responsibilities: 
- Initiates Quality Records and conducts deviation investigations that meeting both Industry and Catalent expectations
- Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
- Develops, executes and oversees CAPAs
-Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
- Supports Tech transfer and process monitoring support as needed
- Works with the team to monitor critical process parameters
- Revision and management of manufacturing documents such as Batch Records and SOPs
- Leads or supports Continuous Improvement projects
-Conducts data gathering, trending, and data presentation as needed to support investigations
- Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.


#m3

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.