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Senior Project/Process Engineer

2022-02-04 12:58:372025-06-27Daksta
Job Type Permanent
Location Boston, MA
Area USA, USA Boston, MA
Market Life SciencesLife Sciences - Engineering
Salary Competitive
Currency GBP
Start Date
Advertiser Courtney Robb
Job Ref MG-5624
Description
Senior Project/Process Engineer (BioPharma) 
Location – Greater Boston, MA 
 
Daksta are currently working with a leading engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. The company is a leader of global pharmaceutical and biotechnology facility design and process engineering and quality system projects. 
 
Their services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies. 
 
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. 
 
Responsibilities 
The role entails the primary job functions: 
 

  • Responsible for generating and tracking performance metrics.
  • Executes engineering tasks and deliverables within schedule and budget constraints.
  • Liaising with our client's management to ensure a productive and professional working relationship. 
  • Maintains knowledge of current good manufacturing practices cGMPs.
  • Regularly working on site, located in Boston, MA.
  • Strong interpersonal, written and oral communication skills.
  • Contributes and supports high-performance, cross-functional teams.
  • Follows site specific work instructions, policies and procedures.
  • Functions as a technical expert on process equipment or systems.  
  • Analyzes and documents production data using standard scientific methods.
  • Leads troubleshooting of operations and generates corrective actions preventive actions CAPAs.
  • Works on multiple projects or tasks of moderate scope and complexity as a team member, requiring minimal supervision.
 
Qualifications 

  • Requires a bachelor’s or master’s degree in Mechanical Engineering, Chemical Engineering or Biochemical Engineering.  7-10+ years of experience in the biotech-pharmaceutical academic or industrial environment.
  • Knowledge of drug substance manufacturing.
  • Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
  • Technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
  • Demonstrated experience with facilities systems and/or manufacturing processes and equipment used in pharmaceutical and biotech manufacturing.
  • Basic knowledge of the Commissioning and Qualification.
  • Boston area based
 
Candidates please note:  Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Interested candidates with direct related experience in US or Toronto locations are encouraged to apply. 

Salary range in US Dollars 
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