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Engineering - Assistant Process Engineer

Job in Devens, Worcester County, Massachusetts, 01434, USA
Listing for: TechDigital Group
Full Time position
Listed on 2026-01-12
Job specializations:
  • Engineering
    Process Engineer, Quality Engineering, Manufacturing Engineer
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below
Location: Devens

Onsite

Qualifications
  • Knowledge of process engineering and science generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent.
  • A minimum of 2 years relevant experience in biopharmaceutical industry or its equivalent.
  • Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment.
  • Understanding of process and equipment validation principles
  • Knowledge of biopharmaceutical facility design and manufacturing operations. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable.
  • Knowledge of project management principles including proficient use of project management tools and software such as MS Project and other collaborative systems.
  • Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization.
Responsibilities
  • Supports the technical transfer and scale-up of biological processes from process development into clinical manufacturing.
  • Authors facility fit reports and schedule adherence to each aspects of the tech transfers.
  • Responsible for interacting with cross functional teams to forecast and procure required raw materials.
  • Assists in the implementation of new technologies from Development into Operations.
  • Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements
  • Compiles data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary.
  • Assists in the review and approval for manufacturing batch records.
  • Actively participates in an environment which fosters safety, quality and continuous improvement in cost and customer service.
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