Manufacturing Technician II

Work Schedule

12 hr shift/days

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 -22 degrees F/-6 degrees C. Office. Strong Odors (chemical, lubricants, biological products etc.). Warehouse. Will work with hazardous/toxic materials.

Job Description

Join Thermo Fisher Scientific and work with a team of collaborative colleagues. Benefit from the support and opportunities provided by a global leader. Contribute to our respected, growing organization's outstanding strategy for the future.

The incumbent will perform tasks and activities as trained, following cGMP, company and department SOPs, and safety regulations. Join our world-class team for an outstanding opportunity to implement innovative solutions and make a significant impact.

Responsibilities

• Operate pharmaceutical production equipment, such as filling lines, autoclaves, and washers, following SOPs and the Batch Record.
• Responsible for formulation activities of production batches which includes formulation and/or dispensing of all the available drug substance(s) and excipients.
• Responsible for parts preparation, washing, and sterilization of materials.
• Responsible for packaging and transfer of the final product to Freezer.
• Always complete all the relevant training before performing any task.
• Closely follow aseptic techniques and practices for aseptic operations.
• Carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area.
• Timely completion of relevant batch record and logbooks for the tasks performed and with adherence to GDP (Good Documentation Practice).
• Transfer materials for manufacturing a batch.
• Prepare filters for test execution and perform FIT (filter Integrity testing).
• Provide for the loading/unloading of the loads/batch from the equipment during production activities.
• Perform stock check of consumables and inform Manager/Lead technician for required materials.
• Follow safety and quality compliance at all times and communicate in a timely manner to the manager if any anomalies are observed.
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Perform all tasks in accordance with the standard operating procedures and maintain strict compliance to GMP at all times. Report all the quality issues immediately to Manager or Lead technician.
• Perform visual inspection, labeling and packaging on finished drug products. Perform in-process sampling on semi-finished drug products. Conduct in-process inspection and checks.
• Any other duties as and when assigned by the Manager.

Requirements

• Minimum with 2 to 3 years of relevant experience in manufacturing industry
• Experience in sterile manufacturing/cleanroom/pharma/semicon industry are an advantage
• Minimum “O” Level, NITEC/ITE education/Diploma in relevant field.