Scientific Process Operator

Company Description Pharmaceutical Company. Job Description 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

Qualifications

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 Additional Information College degree or HS Diploma with +5 years biopharmaceutical industry experience