Descripción y detalle de las actividades
- Manager is responsible for the efficient flow of materials, safe use of ETO, and proper risk management.
- Lead, coordinate, and oversee operations related to ethylene oxide (ETO) sterilization processes, ensuring compliance with national and international regulatory standards (such as NOM, ISO ***** and *****, FDA 21CFR820, and OSHA), current Good Manufacturing Practices (cGMP), health and safety regulations, and customer commitments.
- **Supervises the calibration, warehouse and Operations teams and enforces strict adherence to validated parameter.
- Manager leads the operations team by promoting a culture of discipline, safety, and continuous improvement, while ensuring ongoing training and development of team members.
- Authorize the weekly operations schedule according to priorities and prior commitments made with clients.
- Elaborates, maintains and manages the department budget.
- Oversees inventory control of raw materials, processed and unprocessed product; develops weekly material flow plans.
- Ensure that the work in the area is conducted according to standard operating procedures and quality guidelines, good manufacturing practices, and health and safety regulations.
- Supervise the proper functioning of process control equipment.
- Supervise the biological indicator inventory report for clients for routine processes.
- Initiate and follow up on corrective actions derived from process nonconformities.
- Supervise the ETO gas inventory report.




- Coordinate and approve overtime for Operations staff.
- Creates and presents KPI on the weekly, monthly and quarterly meetings with company stakeholders.
- Work closely with Commercial Team providing updates on the production status of materials at the plant and their scheduling.
- Interfaces with all customers as the customer service representative and provides status of the customer loads on agreed upon timeframes
Experiência y requisitos
- Extensive knowledge of FDA Quality System Regulations (21 CFR 820), ISO ***** and ISO *****.
- Ability to manage multiple projects successfully.
- Strong professional presence with the ability to interact with associates at all levels, including executive management and customers.
- Highly motivated, self-starter with initiative to improve processes.
- Excellent interpersonal skills and a collaborative management style.
- Ability to foster and actively contribute to a positive team environment.
- Demonstrated commitment to high ethical standards and workplace diversity.
- Strong safety commitment.
Ventajas
- Beneficios de acuerdo a la LFT
**Número de vacantes** 1
**Área** Química
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
- Flexible
**Salario mensual neto** $80,000 - $90,000 MXN
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p.
viajar** Si

📌 Operations Manager (Tijuana)
🏢 Empresa reconocida
📍 Tijuana