Kelly Services
Location
Puerto Rico | United States
Job description
Título de Puesto: Manufacturing Technician – Parenteral
Cantidad de vacantes: 1
Área Geográfica: Manati
Tipo de puesto: Technician - Parenteral
Salario: $15.00ph
Available for 12 hrs. rotative shift - from 5am to 5:30pm or 5pm to 5:30am (4to turno) including Saturdays and Sundays.
Job Description:
• Operates and understands the preparation, formulation and filling equipment functions and basic troubleshooting activities
• Cleans, sanitize, and sterilize manufacturing area rooms and equipments.
• 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.
• 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.
• 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.
• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Handles Hazardous and Non hazardous 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 . Bachelor's Degree in Micro, Biology and chemistry can be consider.
• 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, depyrogenation, 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
Available for 12 hrs. rotative shift - from 5am to 5:30pm or 5pm to 5:30am (4to turno) including Saturdays and Sundays.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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