Manufacturing Associate III - Cell Culture - All genders

Beschreibung:

The focus of this job is to perform the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for performing manufacturing operations and requires significant on-the-floor presence, as well as technical subject matter expertise in operations.
Manufacturing Associates III are expected to execute process recipes, monitor equipment and processes, perform basic tasks, including sampling, and routine maintenance of lab equipment. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.

Responsibilities:
* Initiate quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA) and assist in investigations.
* Complete assigned tasks in a timely manner and is proficient in use of quality management systems, safety requirements, and cGMP practices.
* Actively work to complete training requirements.
* With minimal supervision set up, operate, and maintain a majority of MFG equipment; collect data, and write/ update GMP documentation.
* With direction from Floor Lead/ Supervisor, propose and test solutions to MFG Operational problems. Be able to identify when a deviation has occurred.
* Actively participate in departmental teams, NPI. May present run data as applicable.
* Train Jr. level staff.
* Respond to equipment alarms with help of Floor Lead.
* Effectively communicate with Floor Lead/ Supervisor the status of MFG Operations. Document operational requirements in batch records in accordance with cGMP and company guidelines.
* Develop an understanding of equipment and operations used to manufacture biotherapeutics in cGMP manner.
* Demonstrate situational leadership within MFG and company responsibilities.
* Be open to change and manage emotions during periods of organizational change.
* Perform other duties as assigned.

Basic Qualifications:
* Bachelor's degree and 3 years of Manufacturing & Operations experience; or
* Associate's degree and 5 years of Manufacturing & Operations experience; or
* High school diploma / GED and 7 years of Manufacturing & Operations experience

Qualification Requirements:
* Capacity to develop solutions to technical issues of moderate scope
* Train other personnel on equipment operation
* Draft and revise SOPs
* Proven knowledge of cGMP requirements to ensure compliance
* Experience in operations required for the manufacture of biotherapeutics
* Focus on quality and attention to detail
* Ability to organize, analyze/interpret, and effectively communicate data and results
* Motivated, self-starter with strong mechanical aptitude
* Good interpersonal, team, and communication skills
* Troubleshooting skills on Manufacturing equipment including single use equipment
* Experience with Delta V/MES
* Experience with lab equipment/testing

FR : Dans le cadre de sa politique Diversité, (COMPANY NAME) étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, (COMPANY NAME) considers, with equal competences, all applications including people with disabilities