Scientific Process Operator

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