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Manufacturing Associate III

il y a 1 mois


Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

As a key member of our team at Just Evotec Biologics EU, the Manufacturing Associate III will play a crucial role in ensuring the smooth execution of our biologics manufacturing processes. This includes executing process recipes, monitoring equipment and processes, and performing basic tasks such as sampling and routine maintenance of lab equipment. The successful candidate will be expected to comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.

Responsibilities:

  • Perform and monitor critical processes, including column packing, capture and polishing chromatography steps, viral inactivation, viral filtration, and UF/DF operations.
  • Support the introduction of new products and technologies into the facility.
  • Initiate quality records, including non-conformances, Corrective/Preventative Actions, and assisting in investigations.
  • Draft and revise Manufacturing Procedures and Standard Operating Procedures as necessary.
  • Set up, operate, and maintain a majority of 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.
  • Actively participate in departmental teams and NPI, presenting run data as applicable.
  • Train Junior level staff.
  • Respond to equipment alarms with the 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 a cGMP manner.
  • Demonstrate situational leadership within MFG and company responsibilities.
  • Perform other duties as assigned.

Basic Qualifications:

  • Master's degree;
  • Bachelor's degree and 3 years of Manufacturing & Operations experience;
  • Associate's degree and 5 years of Manufacturing & Operations experience;
  • High school diploma/GED and 7 years of Manufacturing & Operations experience.

Preferred Requirements:

  • Single use technology experience;
  • 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;
  • Be open to change and manage emotions during periods of organizational change.

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.