Scientific Process Operator

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in the Upstream 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

• 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 Manufacturing Execution System (MES) would be an advantage

• Mechanical aptitude for assembling and disassembling process equipment would be an advantage

• Process flow aptitude to recognize and understand process pathways

• Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment would be an advantage

Regards,

Sneha Shrivastava

9739673348