Manufacturing Associate II - Purification - All genders

Manufacturing Associates 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:

· Perform and monitor critical processes (i.e., 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 but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA) and assisting in investigations

· Draft and revise Manufacturing Procedures and Standard Operating Procedures, as necessary Train other personnel on equipment operation

· With direct supervision sets up, operates, and maintains MFG equipment; collects data, and writes/ updates GMP documentation. Aids daily MFG Operations by performing support work.

· Escalate issues

· Contribute to the success of MFG through active participation in MFG runs

· Sufficiently 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

· Perform other duties as assigned

Basic Qualifications:

· Bachelor’s degree and 2 years of Manufacturing & Operations experience; or

· Associate’s degree and 4 years of Manufacturing & Operations experience; or

· High school diploma / GED and 6 years of Manufacturing & Operations experience

Preferred Requirements:

· Capacity to develop solutions to technical issues of moderate scope

· Train other personnel on equipment operation

· Knowledge of cGMP requirements

· Experience in operations required for the manufacture of biotherapeutics

· Focus on quality and attention to detail

· Motivated, self-starter

· Good interpersonal, team, and communication skills

· Troubleshooting skills on Manufacturing equipment including single use equipment

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally

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.