Production Operator

under minimal supervision, this position is responsible for operation of pharmaceutical manufacturing equipment in a gmp environment for the purpose of making clinical supplies and performing development experiments. Incumbent is also responsible for leading manufacturing activities in assigned production rooms.

• train on, comply with, and understand all policy and procedures at experic including regulatory, safety, sops, work instructions, etc.
• assist in the development of new processes in procedures under the management direction including:
  • becoming subject matter expert for pharmaceutical manufacturing equipment.
• adapting understanding of equipment into (write) new sops and work instructions and assisting in the training of additional staff on equipment specialty.
• front line troubleshooting of processes and equipment.
• perform pharmaceutical manufacturing activities including:
  • batch documentation/record generation
  • materials sampling, staging, dispensing, and return
  • pharmaceutical equipment and room set-up, operation, and cleaning
  • use of appropriate personal safety equipment and engineering controls
  • in-process inspection and sampling
  • use experic it platform
• perform developmental manufacturing experiments under the direction of management.
• support investigational and quality systems activities.
• assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.
• participate in continuous improvement activities at experic.
• carries out duties in compliance with all federal and state regulations and guidelines.
• complies with all company and site policies and procedures.
• mechanical aptitude, curiosity to explore complex machinery, and a desire to learn new processes.
• an ability to learn and remain self‑directed on tasks that are both well‑defined and more exploratory.
• learn, become and remains current in profession and industry trends.
• makes a positive contribution as demonstrated by:
  • making suggestions for improvement
  • learning new skills, procedures, and processes.
• is available for other duties as required.

requires a bachelor’s degree in an engineering or scientific field with one (1) year of experience in pharmaceutical or life science area or a high school diploma and four (4) years of experience in pharmaceutical manufacturing with an emphasis on working on the implementation of new equipment and processes.

• read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
• communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.

• apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios, and proportions to practical solutions.
• graph data using spreadsheets and perform simple statistical analyses (means, standard deviations, linear regression).

• identify simple and moderate problems related to job function.
• scientific reasoning the ability to gather data based on observations and measurement, formulate hypotheses, propose experimental tests, and draw conclusions, systematically.
• deductive reasoning: demonstrated experience applying general and complex rules to specific problems to produce answers that make sense.
• inductive reasoning: demonstrated experience applying a logical process in which multiple premises, all believed true or found true most of the time, are combined to obtain a specific conclusion (includes finding a relationship among seemingly unrelated events).
• knowledge of cgmp. O familiar with pharmaceutical manufacturing.
• successfully completes regulatory and job training requirements.
• computer skills: enter data into computer using software applications for data entry and word processing. Work and be proficient with e‑mail systems.
• ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• ability to work individually in a self‑directed manner with less than daily oversight.
• ability to work with others in a…