Manufacturing Associate III
il y a 4 semaines
Manufacturing Associates III are expected to execute process recipes, monitor equipment and processes, perform basic tasks, including sampling, and routine maintenance of lab equipment in support of downstream manufacturing operations. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation. Manufacturing Associates III may also assist in media and buffer compounding.
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.
With minimal supervision set up, operate, and maintain a majority of MFG equipment; collects data, and writes/ updates 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 Junior 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.
Perform other duties as assigned.
Basic Qualifications:
Master’s degree; or
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
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.
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