- Title: Biologic Operator
- Code: RCI-08647
- Location: Barceloneta Puerto Rico (PR) 00617
- Posted Date: 06/30/2020
- Duration: 12 Months
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- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Job Title Biologics Operator I
- The Biological 1 manufacturing operator is trained to perform his tasks in one of the three process areas, Central Services, Fermentation and / or Purification.
- It will be assigned in daily production operations, operating equipment such as washing machines, autoclaves, CIP (Cleaning in Place) systems, bioreactors, filtration systems, chromatography equipment.
- It will weigh and verify the necessary raw materials and parts. Will perform pH, conductivity, osmolality and filter integrity tests. It will monitor alarm systems.
- You will assemble equipment and perform the cleaning and sterilization procedures. It will comply with Good Manufacturing Practices (GMP? S) and with standard procedures (SOP's). He will inform the coordinator of his performance area and the supervisor about any event that arises during the shift.
- Attend and complete internally required training on industrial hygiene, occupational safety and good manufacturing practices (cGMP, SARA, CHAP, BOP and others). Use required personal protective equipment (PPE) and report incidents or unsafe conditions in the work area to the supervisor.
- Maintain detailed electronic and paper records of the operations carried out during the work shift,? Batch records ?,? Log books? and perform the required inventory transactions.
- Receive materials for the plant. Weigh and verify raw materials and required materials.
- Monitor processes through computerized systems and visual inspection and recognize when process parameters deviate to alert and take action.
- Inspect the equipment to verify that it is operating within the established parameters.
- The incumbent is responsible for complying with the Abbott Corporation and GPO Policies, with the ABL Plant Procedures and with the regulations and requirements of Good Manufacturing Practices (cGMP) of the Federal Food and Drug Administration. (FDA).
- Perform cleaning, pressure testing, equipment sterilization, small and large scale cell culture, filtration systems, chromatography, and preparation of solutions.
- Take samples in the equipment at different times of the processes, prepare the equipment and carry out laboratory tests as required.
- Preparation of culture medium solutions or buffers for use in the fermentation, capture and purification process.
- Carry out pH, BGA, conductivity, osmolality, and filter integrity tests.
- Provide assistance to operations in the control, management and disposal of domestic, biomedical and hazardous waste in their respective area as applicable, ensuring compliance with Local and Federal regulations following the procedures and policies of the plant, division and the corporation.
- The incumbent must possess skills to analyze, investigate, identify, resolve, and document problems during the manufacturing process.
- Mathematical skills.
- Basic knowledge of computerized systems. Desirable DeltaV, SAP, MES.
- Knowledge of OSHA and safety regulations for corporations, local area and state.
- Knowledge of quality regulations and standards that affect chemical, biological or medical devices (i.e. Quality Systems, FDA Regulations, and EN46000).
- Basic knowledge of laboratory techniques
- Ability to read, write, interpret and communicate instructions in English and Spanish.
- Basic mechanical skills
- Associate Degree in Natural Sciences, preferably in Chemistry, Biology, Microbiology or in related areas. You can have an associate degree in electronics or mechanics with one (1) year of experience in the area of biotechnological processes.
- Candidates with a Bachelor's Degree in Natural Sciences, Biotechnology, Chemistry, MicroBiology, Biology or related areas, no experience can be considered.
- Mathematical skills.
- Basic knowledge of computerized systems, desirable Delta V, MES, SAP.
- Experience in the manufacturing or quality area in the chemical, pharmaceutical or biological process industry, preferably.
- Basic knowledge of laboratory techniques.
- Reading and compression skills of the English language.
- Basic mechanical skills.
1. Ability to work with compressed itineraries.
2. Ability to work in a team.
3. Good interpersonal relationships.
4. Basic skills to identify and analyze chemical and biological manufacturing problems and processes.
5. Ability to read and understand information
6. Transportation of heavy equipment.
7. Knowledge of Good Manufacturing Practices (cGMP's) and safety standards.
8. Basic skills to identify and analyze chemical and biological manufacturing problems and processes.
9. Skill in operating computers (MES, SAP) and automated systems (Delta V).
10. Verbal and written communication in English and Spanish.
11. Availability to work shifts including weekends and rotary.
12. Good interpersonal relationship skills.