Scientific Process Operator

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

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

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 25 lbs

Contact me at 732 429 1924 OR 732 549 2030*244