Production Operator

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.
• 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…