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Associate Biopharma Manufacturing (JP7327)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Associate Biopharma Manufacturing (JP7327)
Location: Thousand Oaks, CA. (Onsite Essentia l)
Employment Type:  Contract
Business Unit: Drug Product Safety NPI/MES Validation
Duration: 2+ years (with likely extensions)
Posting Date: 5/1/20
 
 
3 Key Consulting is hiring a Associate Biopharma Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
Routinely perform complex electronic data entry according to Standard Operating Procedure (SOP).  Specific responsibilities include creation and validation of electronic batch records (EBR) per procedures using Manufacturing Execution System (MES) and ERP.  Additional responsibilities include:
  • Support paper on glass manufacturing batch record process.
  • Translation and understanding of process specifications established by development teams into source documents (paper or electronic) utilized by production teams.
  • Data entry and/or verification within electronic systems.
  • Translation of instruction from paper sources to electronic systems.
  • Internal support operations (e.g., data verification, document management, SOP revisions).
 
 
Why is the Position Open?
Will be a back-fill for worker who will be converting to permanent.
 
 
Top Must-Have Skill Sets:
  • Must have previous biopharmaceutical manufacturing experience.
  • Demonstrable strong communication skills (verbal and written).
  • “Right the First Time” quality-based mindset and attention to detail.
 
 
Day to Day Responsibilities:
Routinely perform complex electronic data entry according to Standard Operating Procedure (SOP). Specific responsibilities include creation and validation of electronic batch records (EBR) per procedures using Manufacturing Execution System (MES) and ERP.  Additional responsibilities include:
  • Support paper on glass manufacturing batch record process.
  • Translation and understanding of process specifications established by development teams into source documents (paper or electronic) utilized by production teams.
  • Data entry and/or verification within electronic systems.
  • Translation of instruction from paper sources to electronic systems.
  • Internal support operations (eg, data verification, document management, SOP revisions).
 
 
Basic Qualifications:
  • Must have previous biopharmaceutical manufacturing experience.
  • Demonstrable strong communication skills (verbal and written), “Right the First Time” quality-based mindset and attention to detail.
  • Targeting Bio-Pharma background. 1+ years of drug product/manufacturing experience.
  • BS Engineering or Biological Sciences
 
 
Employee Value Proposition:
Exposure to entire drug product facility/clinical building. Would not be working with just one area to there is the chance to learn multiple levels. The electronic configuration experience is a rare skill that is transferable to other industries.
 
 
Red Flags:
I would like to only see resumes with individuals that have scientific degrees/background.
 
 
Interview process:
Phone screen, then final interview.
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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