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Manufacturing Engineer / Pharma Biologics

Pioneer Data Systems Inc Cambridge Contractor
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Position Details:
Our client, a world leading Pharmaceutical Company in Cambridge, MA is currently looking for a Manufacturing Engineer / Pharma Biologics to join their expanding team
 
  • Job Title: Manufacturing Engineer / Pharma Biologics
  • Duration: 12 months contract, Extendable up to 36 months
  • Location: Cambridge, MA 02138
 
Note:
  • Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
  • You may participate in the company group medical insurance plan
 
Description:
  • As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Pharmaceutical client manufacturing network and/or Contract Manufacturing Organizations. 
  • You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.
 
  • Domestic and International Travel: up to 15%
 
Specific responsibilities include but are not limited to:
  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
  • Initiate and complete routine technical tasks.
  • Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
  • Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
  • Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
  • Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
  • Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
  • Work with consultants, architects and engineering firms on development of standard design documents.
  • Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
  • Support non-standard shift organization and extended hours, as per business needs.
 
Basic Qualifications
  • Master's degree OR
  • Bachelor's degree and 2 years of Engineering or Operations experience OR
  • Associate's degree and 6 years of Engineering or Operations experience OR
  • High school diploma / GED and 8 years of Engineering or Operations experience
 
Top 3 Must Have Skill Sets:        
  • Education background in Chemical Engineering, Bioengineering or Biotechnoloy
  • 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
  • Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
  • Experience working with commercial manufacture of biologics using single use technology
 
Day to Day Responsibilities:      
  • As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Pharmaceutical client manufacturing network and/or Contract Manufacturing Organizations. 
  • You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.
 
  • Domestic and International Travel: up to 15%
 
Employee Value Proposition:   
  • Lead different projects and get hands on experience
 
Possible Extension:       
  • Yes
 
Red Flags:          
  • No experience in industry.
  • No manufacturing experience (only R&D, lab scale).
 
Interview Process:         
  • Phone screen followed by face to face at Pharmaceutical client site (AMA, Cambridge)   
 
 
 


Education, Experience, Skills:
  • BS with 3+ yrs experience
  • Education background in Chemical Engineering, Bioengineering or Biotechnoloy
  • 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
  • Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
  • Experience working with commercial manufacture of biologics using single use technology


Recommended skills

Manufacturing
Scheduling
Engineering
Pharmaceuticals
Process Engineering
Process Development
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