Pharmaceutical Manufacturing Operator

​​About the Role:

We are looking for a dependable Pharmaceutical Manufacturing Operator who will manufacture sterile medications. As a manufacturing operator, you will keep accurate records, keep up to date with training, and manufacture medications for Hims & Hers Pharmacy.

You Will:

• Operate in ISO 5-8 environments performing essential duties to manufacturing sterile products.
• Routine compounding operations including preparation and sterilization of labware, measuring, compounding, filing semi-automatically and working with automated filling machines.
• Assist and perform compounding, verifying steps, aseptic processing, visual inspecting units for foreign matter, labeling, packaging, and shipping.
• Complete compounding controlled documents and assignments with minimum errors and within an appropriate timeline.
• Ability to perform duties related to material transfer, aseptic processing, and other cleanroom related duties such as cleaning and maintaining the cleanroom equipment.
• Assist with general maintenance of activities related to the facility, and warehouse. 
• Communicate with pharmacists and report on issues in the cleanroom. 
• Restock medication shelves and supply bins; rotate and remove outdated materials and chemicals; maintain a clean working environment. Participate in the inventory as needed. 
• Assist in record keeping according to GDP, and reporting efficiency numbers to the compounding pharmacists. 
• Provide quality assurance assistance to compounding pharmacists. 
• Knowledge of compounding terminology and calculations.
• Perform other duties as assigned by management or quality assurance. 
• Follow GMP, GDP, ALCOA+++, FDA, and other regulatory industry related guidance at all times.  
• Experience participating in a manufacturing unit in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals.

You Have:

• Bachelor’s degree
• A minimum of 2 years sterile compounding experience in a manufacturing setting is required.
• Experience with installation, qualification, and operation of common pharmaceutical equipment such as filter integrity machines, scale, pH meter, analytical balance, auto clave, depyrogenation oven, manual and automated crimper machines, aseptic filling machines, check weighers, sonicator machines, fogging machines, incubator, mixer, air/ nitrogen cylinders, and viable, non-viable air sampler devices. Ability to trouble shoot the machines.
• Experience with sterility via filtration of the products working with different filter types. Familiar with different types of terminal sterilizations. 
• Cleaning, operating, change over, assembling, disassembling of the machine parts for the bag filling, PFS filling, and buffer bag for filling machines.
• Cleaning, operating of the formulation and filtration vessels by performing PHT (Pressure Hod Test), Clean In Place (CIP), Sterilization In Place (SIP), and batch processing using automated system. 
• Knowledge of cleaning and maintaining above mentioned equipment.
• Knowledge of cleaning and maintenance of the cleanroom and familiar with cleanroom layout, air circulations, pressure differentials. 
• Experience working with semi-automated machine and experience manual 100% visual inspection/ AQL under appropriate light, against black/ white back grounds, using a timer. 
• Experience performing weighing of ingredients and mixing, pulling supplies, and material transfer per protocols and batch record steps. 
• Deep Knowledge of cGMP, CFR 21, sterile compounding, and aseptic techniques preferably related to 503 B outsourcing manufacturing facility. 
• Successfully participated in the Aseptic Media Fill process.
• Deep knowledge of line clearance to prevent mix ups and cross contaminations. 
• Performing review of documents for accuracy and completeness at the end of each batch production and follow GDP. 
• Experience working in ISO 5-8 environment and being gowned up for 8-10 hours while taking appropriate breaks. 
• Comfortable wearing respirator and necessary PPEs. 
• Experience working with a team of QA, production, and pharmacists. 
• Experience with investigating process nonconformance or OSS and run an experimental batch to find answers for investigations. 
• Previous FDA trainings desirable. Previous knowledge of working with quality related documentations is desirable.  
• Experience with restocking supplies, PPE, and familiarity with what these items are.
• Knowledge of hazardous and biohazardous waste management. 
• Knowledge of FIFO and inventory management.
• Self-initiator. 
• Great critical thinking and problem-solving skills.
• Ability to work flexible hours, over-time, weekend shift. 
• Experience with labeling and packaging of the final products, and products final counts.

Our Benefits (there are more but here are some highlights):

• Competitive salary & comprehensive health benefits including medical, dental & vision

Conditions of Employment: 

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.