Scientific Process Operator
Position Type :
Experience Level :
Start Date / End Date :
07/08/2013 / 12/27/2013
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
*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
- Basic GMP understanding
- Attend PE awareness classes and may participate PE projects
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
- 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
- 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
This is a Nightshift position. Hours are 7:00 to 7:30 am. Weekend work is required. Work on Holidays is required as schedule rotation dictates.
A10 - 14 months ago