Manufacturing Operations Specialist
il y a 4 semaines
The focus of this role is to execute clinical and commercial manufacturing operations while ensuring compliance with cGMP regulations. This position requires significant on-the-floor presence and technical 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 with written procedures for safety requirements, cGMP practices, Standard Operating Procedures, and manufacturing documentation.
Responsibilities:
- Initiate quality records, including non-conformances, Corrective/Preventative Actions, and assist in investigations.
- Complete assigned tasks in a timely manner and be proficient in quality management systems, safety requirements, and cGMP practices.
- Actively work to complete training requirements.
- Set up, operate, and maintain MFG equipment; collect data, and write/update GMP documentation with minimal supervision.
- Propose and test solutions to MFG operational problems with direction from Floor Lead/Supervisor.
- Participate in departmental teams, NPI, and 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.
- 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, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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