Core Technician

Job Description: Responsible for participating in upstream and/or downstream aseptic manufacturing of clinical and/or commercial grade cell therapeutic products in accordance to established SOPs, maintaining and stocking clean room environment, and monitoring expiration of materials. Completes Cell Therapy Department Training plan in order to contribute to the client specific manufacturing campaigns.

Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Execution of the job related and ancillary processes associated with cell therapy manufacturing:

Demonstrates Technical proficiency and knowledge expansion in:
Equipment Maintenance and Usage
Cell Bank General Aseptic Processing Skills
Demonstrates basic understanding of the high level cell culture foundations and process overview
Demonstrates technical skill proficiency (minimal operator related PRs, excursion hit rate within historical norms)
Demonstrates EM proficiency (limit the number of operator related EM deviations)
Demonstrates proficiency on 1-2 client specific projects
Able achieve 70-75% yearly utilization rate
Able to maintain consistent SOP Compliance rate at or above 95%
Follows Standard Operating Procedures and Master Batch Records as written
Demonstrates basic GMP documentation proficiency
Demonstrates introductory level competency with Trackwise system and problem record initiation
Be able to demonstrate basic Trackwise competency (PR initiation) Qualifications: Understanding and Compliance in the execution of GMPs in a manufacturing environment
Compliance with all safety policies, rules, and general regulations (i.e. Safety Chat attendance, 5S and EPS Observations)

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.