Work Schedule

Flex 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 -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials

Job Description

As a Sr Manufacturing Technician at Thermo Fisher Scientific, you will have the chance to supply to an outstanding team driving scientific innovation. You will be instrumental in maintaining our detailed production processes and ensuring the highest quality standards are met.

Responsibilities

• 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, and inspection and packaging line equipment (e.g., AVIM, labeling, and carton machine), as per relevant SOPs and Batch Record.
• Complete formulation activities for production batches, including the formulation and/or dispensing of all available drug substance(s) and excipients.
• Prepare, wash, and sterilize materials and parts.
• Handle the packaging and transfer of final products to the freezer.
• Complete all necessary training prior to task execution.
• Perform all material and process (SAP) transactions at each manufacturing step.
• Adhere closely to aseptic techniques and practices for aseptic operations.
• Maintain and clean production equipment and classified areas.
• Conduct routine QC sampling and in-process testing of the product at various manufacturing stages.
• Timely completion of batch records and logbooks in adherence to GDP.
• Transfer materials for batch manufacturing.
• Prepare filters for test execution and perform FIT (Filter Integrity Testing).
• Load and unload equipment during production activities.
• Monitor stock levels of consumables and inform the Manager/Lead technician of material requirements.
• Ensure safety and quality compliance at all times and report any anomalies to the Manager promptly.
• Participate in EHS, Business Compliance, cGMP, and other compliance-related activities.
• Report all quality issues immediately to the Manager or Lead technician.
• Perform microbial sampling and swabbing of room and equipment if required.
• Liaise with external vendors for instrument calibration and maintenance.
• Conduct chemical and mathematical calculations to resolve product potency and endotoxin levels if necessary.
• Inspect, label, and package finished drug products and perform in-process sampling and inspections on semi-finished products.
• Undertake any other duties assigned by the Manager.

Education

• Minimum “O” Level, NITEC/ITE education/Diploma in a relevant field.

Experience

• 3 to 5 years of relevant experience in the pharmaceutical industry.

Knowledge, Skills, Abilities

• Good understanding of safe working practices and cGMP.
• Highly motivated to work in the pharmaceutical industry.
• Strong team-player with an ability to work rotating shifts.