Scientific Process Operator

Scientific Process Operator

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in Downstream Manufacturing. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.

Essential functions include:

• 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
• Demonstrates 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 include:

• 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

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
• Basic GMP understanding
• 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

Mathematical skills:

• Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

Other skills, abilities or qualifications:

• Knowledge and ability to operate manufacturing equipment and hand tools

Physical demands:

• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Is frequently required to talk or hear.
• While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms
• Ability to lift 20 lbs

Qualifications

Education and/or experience:

• College degree or HS Diploma with +5 years industrial 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