Position: Manufacturing Technician Pay rate: $13.50 p/h JOB SUMMARY The Manufacturing Technician is responsible for following established instructions for the execution of specific tasks in a biotechnology manufacturing setting, including the execution of manufacturing orders.
The Manufacturing Technician should identify potential problems and bring them to the attention of the supervisor.
He/she participates in continuous improvement projects.
DUTIES AND RESPONSIBILITIES • Material Preparation per established procedures.
• Perform inspection, verification for calibration and maintenance of equipment.
• Maintains related logs and manufacturing records.
• Performs area in-process testing as requested.
• Reclaim and re-test of resins.
• Performs daily working area cleaning tasks.
• Performs packing, cleaning and equilibration of chromatography columns as requested and scheduled.
• Maintains inventory of chemicals and lab supplies required for manufacture.
Completes material order transactions in SAP system and performs the required inventory control activities to maintain accuracy.
• Support set up and manufacturing activities for the following areas: tissue culture, purification and conjugation.
• Processes cell supernatant to remove debris and to concentrate product before purification.
• Formulates monoclonal antibody reagents using established documentation.
• Manufactures buffers and solutions using established procedures.
• Uses equipment such as pipettes, micro-pipettes, balances, pH and conductivity meters, and UV/Visible spectrophotometers.
• Executes assigned manufacturing tasks.
• Execute Filling & Packaging process by scheduling, filling, labeling, bagging, pouching and vialing for: pellets, purified and conjugated materials, as required.
• Promotes a safe work environment by providing recommendations on maintaining the safety of the work environment, following safety procedures, participating in Environment Health and Safety (EH&S) programs, initiating a corrective action whenever a hazard is identified, notifying supervisor of all observed hazardous conditions or unsafe work practices.
• Supports Quality Assurance by keeping abreast of the basic requirements for compliance in own area of work and complies with those requirements, participating as required in training on regulatory issues affecting own area of work, bringing regulatory compliance questions/issues to next level of management.
• Maintain good housekeeping practices.
• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
• Participates in Continuous Improvement initiatives.
• Performs other related duties and assignments as required.
MINIMUM QUALIFICATIONS KNOWLEDGE AND SKILLS • Knowledge of aseptic techniques.
• Knowledge of methods required to perform in process testing.
• Knowledge of the operation of related instrumentation such as Spectrophotometers, centrifuges, balances, conductivity meters, micropipettes, CO2 Incubators, Microscopes Micro plate readers, centrifuges, pipettes and Biosafety Hoods • Knowledge in the manufacture of dilutions, buffers and solutions.
Document: JD-MFG-017-PR Doc Type: ZBI Status: Released EFFECTIVE Revision: 01 Change #: 500000096089 Print Date: 03-Aug-2022 21:42:59 GMT Daylight Time Usage: Production Usage Version: A Classification: Restricted Valid From: 10-Apr-2018 To: 31-Dec-9999 Doc Part: EN BD Biosciences Confidential LOCATION: Cayey, Puerto Rico FLSA STATUS: Non-Exempt • Strong Mathematics skills.
• Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable.
• Working knowledge on MS Windows environment software such as MS Office.
• Effective skills on interpersonal relationships, written and oral communication, and planning/organization.
• Demonstrated ability to follow established policies and procedures.
• Ability to speak, read and write English.
• Ability to speak, read and write Spanish.
• Attendance and punctual EDUCATION AND EXPERIENCE Requires an Associate Degree as a minimum and a minimum of one year of experience in a laboratory or pharmaceutical/medical device/biotechnology environment or equivalent combination of related education and experience.
MENTAL DEMAND Apply, commonsense understanding to carry out detailed written or oral instructions.
Manage stressful situations.
PHYSICAL DEMAND Frequently, the work requires carrying, lifting and pushing heavy level objects.
In addition, frequently requires pulling medium level objects.
Constantly, the job requires standing, walking, sitting, climbing, balancing, stooping, reaching, handling, fingering, talking, hearing and seeing (near/far/depth perception/visual color discrimination).
Occasionally, the work requires kneeling.
WORKING ENVIRONMENT The work is performed constantly inside the building.
The work requires exposure to extreme cold with or without temperature changes.
Also, requires the exposure to wet and/or humid conditions.
The work environment has hazards exposures (mechanical-equipment, electrical and burns) and atmospheric conditions (fumes and odors).