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Bioprocessing Associate II

Manufacturing | Research Triangle Park, NC | Full Time

Job Description

 

Responsibilities:

  • Proficient on processes and equipment and serves as a hands-on resource in Manufacturing.
  • Conducts all assigned activities in a safe and cGMP manner.  Tasks will include, but are not limited to:
    • Cleaning and preparing production equipment
    • Cleaning and disinfecting production rooms
    • Assembly, set-up, and disassembly of production equipment
    • Executing process steps according to defined SOPs and BPRs
    • Documenting activities in accordance with cGMPs
    • Handling chemically hazardous goods
    • Interfacing with process automation and electronic business systems
    • Supporting projects of medium scope (e.g. operational excellence, safety)
    • Revising SOPs and BPRs
    • Supporting qualification and validation activities
    • Qualified trainer on minor tasks and equipment
    • Recognizing and troubleshooting process issues and initiating deviations with oversight
  • Supports the collection and tracking of area metrics and process control data
  • Supports team effort in the effective and timely completion of root cause investigations and CAPA implementat

Requirements:

  • High school diploma / GED required, preferably coupled with Biotechnology coursework; bachelor’s degree in science preferred.
  • Works within standard operating procedures (SOPs) and/or scientific methods.

  • Has developed analytical skills and application of scientific methods or operational processes to perform a variety of activities.

  • Recognized and solves typical problems that can occur in own work area without supervisory approval; evaluates and selects solutions from established operating procedures and/or scientific methods.

  • Works within defined processes and methods and may help determine the appropriate approach for new assignments.

  • Has a good understanding of how the team integrates with others.

  • Works as a team player, participating in activities that involve cooperating with others.

  • Reviews standard or freely available information to better understand the cause of a problem.

  • Attempts to solve problem before seeking supervisor support.

  • Demonstrates ability to differentiate between important and less important tasks within own work and act accordingly.

Bonus Points:

  • Demonstrated leader with high school diploma / GED or associate’s degree with 2+ years industry related experience (pharmaceutical, biotechnology, and/or sterile production environments) preferred OR bachelor’s degree with 1+ years’ industry experience preferred OR equivalent.
  • Basic knowledge of cGMP requirements required.
  • Experience executing SOPs and documenting work required.
  • Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred.

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 3 Weeks’ Vacation
  • 5 Personal Floating Days
  • 8 Sick Days
  • 6 Company Holidays
  • Career Development and Training