Scientific Process Operator

Pharmaceutical Company. POSITION SUMMARY:  This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in the Operations Services group. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.  ESSENTIAL FUNCTIONS:   Executes manufacturing processes according to Technical Operations and Operational Services standard operating procedures   Verifies and enters production parameters per SOP and Batch Record on trained procedures   Retrieves and analyze trend charts and process data on trained procedures   Accurately completes documentation in SOP's, logbooks and other GMP documents   Demonstrate training progression through assigned curriculum   Accountable for adherence to compliance policies and regulations   Wear the appropriate PPE when working in manufacturing and other hazardous working environments   Takes necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors  ADDITIONAL RESPONSIBILITIES/DUTIES:  • Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA.  • Adheres to the Safety Code of Conduct and attend all required EHS training  • Support the ongoing production schedule by:  • Report to work on-time and according to the shift schedule  • Be available for other duties as assigned  • Attend departmental and other scheduled meetings  • Good interpersonal and communication skills  • Demonstrates positive team-oriented attitude in the daily execution of procedures  • Promote and work within a team environment  • Continue professional development through learning new skills, procedures, processes  and seminars  *This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.  ESSENTIAL FUNCTIONS PER JOB LEVEL:  Autonomy and Complexity   Basic Technical Knowledge within functional area   Introduced to troubleshooting of routine manufacturing processes   Needs direction to perform daily tasks   May offer suggestions for process improvements   Good understanding of cGMP   Attend PE awareness classes and may participate PE projects  COMPUTER ABILITY:   Computer literate   Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required   Ability to learn and operate a range of industry systems including SAP Production, Werum MES, Compliance-Kaplan Wire and others  LANGUAGE SKILLS:   Read and interpret documents such as safety rules, operating instructions and logbooks   Review and provide feedback for SOP and Batch Record revisions.  REASONING ABILITY:   Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.   Follows both verbal and written instructions (100% adherence to SOPs)   Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists   Work with high level of concentration   Accept and adapt to procedural changes  EDUCATION and/or EXPERIENCE:   College degree or HS Diploma with +5 years biopharmaceutical industry experience   Experience must be Biotech/Pharmaceutical industry or relevant experience working with Standard Operating Procedures (SOP's) where formal documentation is required   Previous experience with MES would be an advantage   Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment would be an advantage  College degree or HS Diploma with +5 years biopharmaceutical industry experience