Job Description :

Work Schedule

Flex 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, 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.)

PLEASE NOTE: This is a 12-hours rotating shift role

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Whenyou'repart of the team atThermoFisher Scientific,you'lldo important work. Surrounded by collaborative colleagues,you'llhave the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on ourstrong teamand help us make meaningful contributions to the world.

The incumbent will perform various tasks and activities listed below for which they are appropriately trained andare in compliance withthecGMP, company and department SOPs and the safety regulations.

Responsibilities

Setup andoperatepharmaceutical production equipment including high-speed filling lines for sterile products,autoclave,partsand vial washers,depyrogenationtunnel,formulation process,HMIand automatic CIP/SIP processes as well asinspection and packaging line equipment (e.g.AVIM, labelling and carton machine etc.) as per relevant SOPs and the Batch Record.
Responsible for formulation activities of production batches whichincludesformulation and/or dispensing of all the availabledrug substance(s) and excipients.
Responsible forparts preparation,washingand sterilization of materials.
Responsible for packaging andtransfer ofthe final product to Freezer.
Always complete all the relevant training before performing any task.
Responsible to perform all the materials and process (SAP) transactions at each manufacturing processsteps.
Strictly follow aseptic techniques andpractices practicefor aseptic operations.
Carry out the cleaning and upkeepof the production equipment and classified areas inmanufacturingarea.
Perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing (e.g.bioburden sampling, waler sampling) and chemical and physical tests during the processing of the batch (e.g.pH testing), if applicable.
Timely completion of relevant batchrecordand logbooks for the tasks performed and with adherence to GDP (Good Documentation Practice).
Transfer materials for manufacturinga batch.
Prepare filters for test execution and perform FIT (filter Integrity testing).
Provide forthe 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 timesand communicatein a timely mannerto theManagerif any anomalies areobserved.
Participate in EHS, Business Compliance,cGMPand all other compliance-related matters, where applicable.
Perform all tasksin accordance withthe standard operating procedures andmaintainstrict compliancetoGMP at all times. Report all the quality issuesimmediatelytoManageror Lead technician.
If required, perform Microbial sampling and swabbing of room and equipment.
Liaison external vendors for instrument calibration and maintenance.
If required and depending on product requirement, perform chemical and mathematical calculations todetermineproduct potency and endotoxin levels for eachbatchformulation.
Perform visual inspection,labelingand 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 O Level, NITEC/ITE education/Diploma in relevant field.
Minimum 3 to 5 years of relevantexperiencesinpharmaceuticalindustry.
Good understanding of safe working practices and cGMP.
Highly motivated to work in pharmaceutical Industry.
Able to work as a team.
Able to work rotatingshift.

Sr Pharmaceutical Technician