Manufacturing Associate I-III - Fill Finish Operations

Industry

Manufacturing and Production

Advert ID

USA_422031

Location

Beltsville

Job Type

Permanent

Hours

Full-Time

Salary Range

USD45000-75000 per year

No. of Openings

1

Branch Information

Bethesda, MD - (USA) 4800 Hampden Lane Suite 200 MD Bethesda , MD - 20814 Phone : 301-215-6346

ContactNumber

301-215-6346

Job Description

Manufacturing Associate I-III - Fill Finish Operations to executive cGMP liquid filling and lyophilisation operations.



Responsibilities:

Performs all aspects of liquid filling operations including formulation, media simulations, steam sterilization, Clean-In-Place (CIP), batch record execution, and following complex SOPs.

Assists in the development and execution of process equipment validation protocols during a time when liquid and powder filling operations are idle.

Assists with the development of manufacturing Gantt charts.

Operates mechanical equipment including liquid filling machines, Clean in Place (CIP) systems, lyophilizers, autoclaves, etc.

Troubleshoots, maintains and cleans bioprocess equipment.

Revised and updates SOPs, batch records, and other manufacturing documentation as required.

Collects manufacturing data.

Contributes to continuous improvement and implementation of best practices.

Investigate batch and technical related deviations.

Propose and complete CAPAs as part of deviation investigations.

Contributes to the validation of all aspects of liquid filling operations.

Trains less experienced personnel on department procedures.

Works in cleanroom and BSL-II facilities.

Effective communication with support groups to complete production activities.



Qualifications:

Bachelor's Degree in Biological Sciences, Engineering or Chemistry preferred.

2-5 years of cGMP manufacturing experience.

Experience executing cGMP documentation including SOPs and Batch Records.

Experience in all aspects of semi-automated, automated liquid filling operations and lyophilization operations is required.

Experienced in troubleshooting automated filling equipment is a plus.

Experience with M&O Perry automated filling lines is preferred.

General experience in a variety of cGMP manufacturing and support equipment.

Willing to work evenings and weekends to accommodate production schedules.

Must have excellent oral and written communications skills