Scientific Process Operator

Job Description:

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: 

• 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 

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 

• 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: 

While performing the duties of this job, the employee: 

• 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

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 

Warm Regards

Sneha Shrivastava

732-549- 5307