AI / ML Engineer

Keysight Technologies; Murcia; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Ein etabliertes Unternehmen sucht einen Deputy Manufacturing Manager, der für die Überwachung der aseptischen Fertigung in einer Reinraumumgebung verantwortlich ist. In dieser Rolle gewährleisten Sie die Einhaltung von cGMP-Vorschriften und leiten Prozessverbesserungen, während Sie ein Team von 4 bis 6 Fachkräften führen. Sie arbeiten eng mit Wartungs-, Ingenieur- und Qualitätsteams zusammen, um die Effizienz und Compliance der Produktion zu optimieren. Wenn Sie über fundierte Kenntnisse in der aseptischen Fertigung verfügen und eine Leidenschaft für kontinuierliche Verbesserung haben, ist dies die perfekte Gelegenheit für Sie.

Formación

• Mindestens 5 Jahre Erfahrung in der aseptischen Fertigung oder Sterilverarbeitung.
• Starke Kenntnisse der cGMP- und FDA-Anforderungen.

Responsabilidades

• Überwachung aller Aspekte der aseptischen Fertigung, einschließlich steriler Abfüllung und Inspektionsprozesse.
• Führung und Anleitung eines Teams von 4 bis 6 direkten Berichten.

Conocimientos

Aseptische Fertigung

Führungskompetenz

Problemlösungsfähigkeiten

Regulatorische Anforderungen (cGMP, FDA, EMA)

Teammanagement

Technische Expertise in aseptischen Techniken

Kommunikationsfähigkeiten

Educación

Bachelor in Biotechnologie oder Pharmazie

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Job Title : Deputy Manufacturing Manager

About the Job :

The Deputy Manufacturing Manager is responsible for overseeing and managing aseptic manufacturing operations within a cleanroom environment. This role ensures compliance with cGMP regulations, leads process improvements, and provides strong leadership to a team of supervisors and operators. The Deputy Manufacturing Manager will directly oversee 4 to 6 direct reports and support a manufacturing division of approximately 120 personnel involved in the production of mammalian or microbial-based pharmaceutical or biologic products.

Key Responsibilities :

• Oversee and manage all aspects of aseptic manufacturing, including sterile filling, lyophilization (if applicable), capping, and inspection processes.
• Ensure strict adherence to aseptic techniques, environmental monitoring, and gowning requirements to maintain sterility assurance.
• Provide leadership and guidance to a team of 4 to 6 direct reports, fostering professional growth and ensuring alignment with operational goals.
• Support and oversee a broader manufacturing division of approximately 120 personnel, ensuring operational efficiency and compliance.
• Collaborate with maintenance, engineering, and quality teams to troubleshoot equipment issues and ensure minimal downtime.
• Drive continuous process improvements, optimizing manufacturing efficiencies while maintaining compliance with FDA, EMA, cGMP, and other regulatory requirements.
• Participate in regulatory audits and inspections, ensuring documentation accuracy and process validation compliance.
• Maintain and approve manufacturing documentation, including SOPs, batch records, deviations, CAPAs, and change controls.
• Lead investigations into process deviations and implement corrective and preventive actions (CAPAs) to ensure ongoing compliance and operational excellence.
• Foster a culture of safety, compliance, and continuous improvement across the manufacturing team.

Requirements :

• Minimum of 5+ years of experience in aseptic manufacturing, fill-finish operations, or sterile processing within the pharmaceutical or biotech industry.
• Strong understanding of cGMP, FDA, EMA, and other regulatory requirements related to sterile manufacturing.
• Proven leadership and team management experience, with a history of successfully leading and mentoring teams.
• Technical expertise in aseptic techniques, cleanroom environments, and validation processes.
• Experience managing a team of 4 to 6 direct reports, with oversight of a larger manufacturing workforce.
• Background in mammalian or microbial-based biologics manufacturing is preferred.
• Excellent problem-solving skills and ability to drive continuous improvement initiatives.
• Strong communication skills and ability to collaborate across departments.
• Fluent in English & Spanish (required).

Email Applicants :