The Scientific Process operator position is responsible for performing manufacturing procedures and the execution of scheduled tasks. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.
- Executes manufacturing processes according to Standard Operating ProceduresVerifies and enters production parameters per SOP and Batch Record on trained procedures
- Retrieves and analyse trend charts and process data on trained procedures
- Accurately completes documentation in EBRs, 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
- Carries out duties in compliance with all state and federal regulations and guidelines
- 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 as required
• 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.
- 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
- Read and interpret documents such as safety rules, operating instructions and logbooks
- Review and provide feedback for SOP and Batch Record revisions.
- 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
- 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