Manufacturing Operator
This job was originally posted in Spanish and automatically translated to English.
Job Description
Job Description
Job Description - Manufacturing Operator
About the position
We are looking to incorporate a person with experience in aseptic manufacturing to be part of the Blending Paracox team. The selected person will participate in the commissioning and operation of manufacturing, filling, and packaging processes for sterile products, contributing to ensuring the highest standards of quality, safety, and compliance with GMP regulations.
Important: until the effective incorporation into the Blending Paracox area, the selected person will provide their services in IPT-Sterile Production, where they will acquire knowledge of the processes and the organization before integrating into the new team.
Responsibilities
- Execute aseptic manufacturing, aseptic filling, and packaging operations.
- Complete manufacturing documentation in accordance with GMP requirements.
- Participate in cleaning, preparation, and format changeover activities.
- Detect, communicate, and record incidents, deviations, and opportunities for improvement.
- Collaborate in the qualification, validation, and commissioning activities of the new facility.
- Ensure compliance with quality, safety, and risk prevention standards.
- Work in coordination with the rest of the team to ensure the continuity and efficiency of the production processes.
Working hours
- Availability to work Monday to Sunday, in three shifts, with 24-hour coverage.
Requirements
- Demonstrable experience in aseptic pharmaceutical production.
- Knowledge and experience in blending, filling, and packaging processes for sterile products.
- Knowledge of GMP regulations and experience working in cleanrooms.
- Availability to work shifts.
- Ability to work in a team, quality orientation, and a proactive attitude.
- Experience in the commissioning of new pharmaceutical lines or facilities.
- Knowledge of GMP Annex 1.
Required Skills:
Analytical Thinking, Analytical Thinking, Cleanroom Gowning, Computer Literacy, Driving Continuous Improvement, Equipment Set Up, Fabrication Processes, GMP Environments, GMP Operations, Good Manufacturing Practices (GMP), In-Process Control (IPC), Manufacturing Processes, Problem Resolution, Process Manufacturing, Production Operations, Production Processes, Production Scheduling, Product Quality Assurance, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Standards, Recordkeeping, Risk Prevention, Safety Protocols, Standard Operating Procedure (SOP) Management {+ 1 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
07/16/2026View original advert (Spanish)
Job Description
Job Description - Operario/a de Fabricación
Sobre el puesto
Buscamos incorporar una persona con experiencia en fabricación aséptica para formar parte del equipo de Blending Paracox. La persona seleccionada participará en la puesta en marcha y operación de procesos de fabricación, envasado y empaquetado de productos estériles, contribuyendo a garantizar los más altos estándares de calidad, seguridad y cumplimiento de la normativa GMP.
Importante: hasta la incorporación efectiva al área de Blending Paracox, la persona seleccionada prestará sus servicios en IPT-Producción de Estériles, donde adquirirá conocimiento de los procesos y de la organización antes de integrarse en el nuevo equipo.
Responsabilidades
- Ejecutar operaciones de fabricación aséptica, envasado aséptico y empaquetado.
- Cumplimentar la documentación de fabricación conforme a los requisitos GMP.
- Participar en las actividades de limpieza, preparación y cambio de formato.
- Detectar, comunicar y registrar incidencias, desviaciones y oportunidades de mejora.
- Colaborar en las actividades de cualificación, validación y puesta en marcha de la nueva instalación.
- Garantizar el cumplimiento de las normas de calidad, seguridad y prevención de riesgos.
- Trabajar en coordinación con el resto del equipo para asegurar la continuidad y eficiencia de los procesos productivos.
Horario laboral
- Disponibilidad para trabajar de lunes a domingo, en tres turnos, con cobertura de 24 horas.
Requisitos
- Experiencia demostrable en producción farmacéutica aséptica.
- Conocimiento y experiencia en procesos de blending, envasado y empaquetado de productos estériles.
- Conocimiento de la normativa GMP y experiencia en trabajo en salas limpias.
- Disponibilidad para trabajar a turnos.
- Capacidad de trabajo en equipo, orientación a la calidad y actitud proactiva.
- Experiencia en puesta en marcha de nuevas líneas o instalaciones farmacéuticas.
- Conocimientos de Anexo 1 GMP.
Required Skills:
Analytical Thinking, Analytical Thinking, Cleanroom Gowning, Computer Literacy, Driving Continuous Improvement, Equipment Set Up, Fabrication Processes, GMP Environments, GMP Operations, Good Manufacturing Practices (GMP), In-Process Control (IPC), Manufacturing Processes, Problem Resolution, Process Manufacturing, Production Operations, Production Processes, Production Scheduling, Product Quality Assurance, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Standards, Recordkeeping, Risk Prevention, Safety Protocols, Standard Operating Procedure (SOP) Management {+ 1 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
07/16/2026Application managed by MSD