Manufacturing Technician - Parenteral

Weil Group, Inc; Manatí (PR); On-site; USD 17,000 - 24,000; Full time

Job summary

Weil Group, Inc en Puerto Rico busca un operador de fabricación de parenterales para configurar equipos, limpieza, esterilización y control de pH durante el proceso de formulación. Se requiere diploma de secundaria y experiencia en fabricación farmacéutica, con conocimiento de GMP y documentación de lote.

El candidato trabajará con supervisión mínima, participará en auditorías y en mejoras de procedimientos. Se ofrecen turnos de 12 horas, y pago por hora, con horas extra a tarifa doble.

Qualifications

• Título de secundaria con 2 años de experiencia en procesos de fabricación parenteral o 3 años en fabricación farmacéutica.
• Conocimientos de preparación, formulación y llenado.
• Habilidad para trabajar con supervisión mínima.
• Conocimiento de GMP, EHS y documentación.

Responsibilities

• Operar y entender funciones de equipo de preparación, formulación y llenado; realizar CIP/SIP y verificación de calibraciones.
• Limpieza, desinfección y esterilización de áreas y equipos; ejecución de pruebas de integridad de filtros.
• Recepción y verificación de excipientes y materias primas; ejecución de formulación conforme al lote.
• Gestión de documentación de lotes, auditorías y mejora de procedimientos.

Skills

Manufactura parenteral

Gestión de documentación de calidad

Ensayos de laboratorio básicos

Trabajo en equipo

Education

Diploma de secundaria

Tools

PLC

HMI

Calibración de instrumentos

Job description

Paga 15.00 p/h con disponibilidad a turnos de 12 horas. Overtime es a doble

1. Performs the assigned activities related to the equipment set-ups, changeovers equipment cleaning, and line clearance to achieve an efficient operation of the different processes and products yield maximizing.

• Operates and understands the preparation, formulation and filling equipment functions and basic troubleshooting activities
• Cleans, sanitize, and sterilize manufacturing area rooms and equipment’s.
• Runs autoclaves to sterilize equipment to be used in the manufacturing process.
• Performs CIP and SIP (Cleaning in Place and Sterilization in Place) of the tanks.
• Performs integrity test of all filters used in the process before and after each use.
• Receives, handle, verifies and weigh excipients and drug substance and or active ingredient to be used in the formulation process.
• Executes the product formulation as per Batch record and Procedure instructions; this includes pH measurements and adjustments, yield calculations, and volume adjustment.
• Performs sampling of bulk solutions as per batch record requirements.
• Interacts with computer-controlled equipment and processes.
• Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.
• Verifies calibration status of critical instruments before process operation.
• Operates in an efficient manner of the manufacturing processes to maximize product yield of products.
• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Performs systems integrity test such as isolators, ultra-filtration skid, distribution systems, filters and gloves as required.
• Complete production documentation legible, error free and on time following good documentation practices.

2. Ensures the completeness and compliance of all required documentation during the manufacturing process.

• Maintains inventory and request all necessary components and operating materials.
• Receives, verifies all production records and transaction documents to be error free and in compliance with established procedures, including computer generated transactions.
• Completes production documentation legible, error free and on time following good documentation practices.
• Audits batch records and documentation, as required.
• Assures that the Compounding equipment is in good working condition, clean, labeled, and calibrated and/or qualified according to applicable SOP’s before performing the formulation process.
• Revises and improves procedures and develops new SOPs based on observations and experiences.

3. Provides assistance and supports to manufacturing related activities

• Initiates, participates, and assists in resolution of quality investigations.
• Assists in “on the job training” for new employees.
• Participates in special projects and during audits and regulatory inspections as required.
• Participates and assists in area validation and qualification activities.
• Supports Environmental Monitoring Program by assuring samples collection on established timeframe.
• Supports Annual Requalification Program by assuring plan execution on established timeframe.
• Assists manufacturing activities in other areas within operations as required.
• Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to supervision, as requested by supervisor.

4. Performs GMP Safety and Environmental regulatory tasks required in the manufacturing area.

• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Handles Hazardous and Nonhazardous waste according to EHS procedures.
• Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.

KNOWLEDGE/ EDUCATION/ EXPERIENCE:

• High school diploma with, two (2) years of experience in Parenteral Manufacturing Process or three (3) years of experience in pharmaceutical manufacturing process.
• Knowledge of preparation, formulation and filling processes.
• Basic writing skills when completing area documentation.
• Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes.
• Ability to work with minimum supervision.
• Ability to provide job training, theoretical and or On the Job, for new employees following the Parenteral Operations Department Qualification Curriculum.
• Knowledge of all critical process parameters and their impact in product quality.
• Knowledge in steam sterilization, dehydrogenation, filtration sterilization, lyophilization and isolators technology.
• Understanding of Process Equipment set-up and able to perform it repeatedly and according to SOPs.
• Ability to apply critical thinking to resolve complex issues.
• Excellent leadership characteristics, accountability and commitment.
• Team player and collaborating skills.
• Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
• Skill in performing detailed tasks and documenting information.
• Ability to enter data into a computer and perform complex process transactions.
• Skill in accurate visual inspection (e.g. product and components defects)
• Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
• Skill in basic mathematical applications.
• Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
• Strong organizational skills