Manufacturing Specialist PC 555

Miltenyi Biomedicine•San Jose, CA

1d•$80,591 - $94,903•Onsite

About The Position

This position is responsible for a variety of activities supporting the Manufacturing Operation. The responsibilities include but not limited to the following: ensuring proper documentation and response to all manufacturing-related quality events, business process ownership, process improvement initiatives, tracking and trending operational performance, and training. In addition, this position will provide subject matter expertise and technical support to the manufacture of biologics under cGMP conditions.

Requirements

Bachelor's Degree from a four-year college or university
At least 2 years of related experience in a GMP or research manufacturing environment.

Responsibilities

Perform on the floor duties as needed.
Oversee the initiation and timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Requests.
Coordinate the development, writing, and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
Performs manufacturing review of logbooks and executed records.
Participate in internal and external audits as a manufacturing Subject Matter Expert (SME).
Adheres to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.
Provide technical and operational leadership, assists Department head to ensure on time execution of operations; may provide day-to-day supervision to junior staff.
Provide technical leadership.
Troubleshoot processing issues, investigating in detail and establishing root cause and resolution/corrective action.
Support validation activities as needed.
Help to train the junior staff as needed.
Drive Process Improvement initiatives using Lean Principles.
Supports the management of performance management metrics.
Other Manufacturing activities to assure successful operations.