Work Schedule
12 hr shift/nights
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
Responsibilities
As a Manufacturing Technician II, you will play a key role in our world-class manufacturing team, ensuring the detailed production of pharmaceutical products. Your responsibilities include:
* Setup and operate pharmaceutical production equipment, including high-speed filling lines for sterile products, autoclave, parts and vial washers, depyrogenation tunnel, formulation process, HMI, and automatic CIP/SIP processes, as well as inspection and packaging line equipment (e.g., AVIM, labeling, and carton machine) as per relevant SOPs and Batch Records.
* Coordinate formulation activities of production batches, including the formulation and/or dispensing of all available drug substances and excipients.
* Handle parts preparation, washing, and sterilization of materials.
* Handle packaging and transfer of the final product to the freezer.
* Ensure all relevant training is completed before performing any task.
* Adhere closely to aseptic techniques and practices during aseptic operations.
* Maintain the cleanliness and upkeep of production equipment and classified areas.
* Complete relevant batch records and logbooks timely and in strict adherence to GDP (Good Documentation Practice).
* Transfer materials for manufacturing a batch.
* Prepare filters for test execution and perform FIT (Filter Integrity Testing).
* Load and unload the equipment during production activities.
* Conduct stock checks of consumables and inform the Manager/Lead Technician of required materials.
* Follow safety and quality compliance at all times and communicate any anomalies to the manager promptly.
* Participate in EHS, Business Compliance, cGMP, and all other compliance-related matters.
* Perform tasks in accordance with standard operating procedures and maintain strict compliance with GMP at all times. Report all quality issues immediately to the Manager or Lead Technician.
* Conduct visual inspection, labeling, and packaging of finished drug products. Perform in-process sampling on semi-finished drug products and conduct in-process inspections and checks.
* Undertake any other duties as assigned by the Manager.
Education
* Minimum “O” Level, NITEC/ITE education/Diploma in a relevant field.
Experience
* 1 to 2 years of relevant experience in the pharmaceutical industry or 3 to 5 years of working experience in any industry.
Knowledge, Skills, Abilities
* Good understanding of safe working practices and cGMP.
* Highly motivated to work in the pharmaceutical industry.
* Strong great teammate.
* Ability to work rotating shifts.
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