Manufacturing Associate IV (FT) 22721

Headhunters, LLC's client is seeking a Manufacturing Associate IV.

Job Summary

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture biological products. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities. Assumes a leadership role in the absence of the Supervisor. Proficient in SAP transactions including work notifications, document revisions, change controls and non-conforming events. Some night and weekend work may be required.

Responsibilities

-Operates biopharmaceutical manufacturing equipment such as: incubators, bioreactors, depth filtration skids, tangential flow filtration skids, chromatography skids, mixers and in process testing equipment

-Completes training and demonstrates competency on Manufacturing Associate qualification blocks in accordance with the training progression pathway

-Ensures the facility is maintained in a state of environmental control.

-Demonstrates, understands and adheres to Emergent policies, cGMP guidelines and safety procedures

-Informs management on progress of projects, transfer of data, process details, etc.

-Executes controlled documentation (SOP’s, Production Batch Records, Technical Reports, Protocols, etc.) according to cGMP guidelines and site quality standards

-Write and revise controlled documents as assigned

-Initiates Non-Conforming Events and perform/document all necessary containment activities. Escalates non-conforming events to management in real-time to ensure appropriate corrections/containment is completed.

-Provide regular feedback to Manufacturing Supervisor on performance of Associates assigned to the area.

-Ensure the appropriate level of communication is disseminated to the subsequent shift and impacted support departments regarding process and equipment status.

-Make routine and non-routine process related decisions in accordance with cGMP standards.

-Collaborates with the Manufacturing Supervisor to ensure staffing is adequate to meet the production needs of the area through routine distribution of personnel

-Facilitate routine meetings in the manufacturing area to ensure consistent communication updates to all team members

-Coordinate and monitor associate break schedules.

-Identifies and initiates changes in the change control system through collaborative efforts with QA and various departments in response to deviations, CAPA’s and continuous improvement projects.

-Collaborates with support personnel to ensure proper execution of product development protocols, technical studies and corrective/preventative maintenance.

-Demonstrates proficiency in all job specific SAP modules

-Proactively recognize potential issues with process equipment and troubleshoot in collaboration with Facilities/Maintenance

-Acknowledge GMP alarms and perform follow up to ensure minimal impact. Escalates alarms to management as appropriate.

-Review generated documentation for accuracy, data entry and completeness of each step

-Ensures that Batch Production Records are requested and obtained in accordance with the production schedule

-Trains other associates in the operation of minor manufacturing equipment.

-Verification of execution of preventative maintenance of equipment. Requires thorough understanding of operation and function for intended purpose

-Responds to off-hour alarms as assigned by management

-Participate in various site/company initiatives

Requirements

-High School diploma and 12-15 years’ experience in biopharma manufacturing or Bachelor’s degree in physical or life science and 7-9 years’ experience in biopharma manufacturing

-Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware

-Computer literate (Word, Excel and PowerPoint)

-Ability to work independently with limited supervision

-Previous SAP experience preferred

Please send resume and cover letter to Meredith: Meredith@headhuntersllc.org