Process Engineer

Billerica, MA, US • Posted 15 hours ago • Updated 12 hours ago
Contract W2
12 Months
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Process Engineering
  • Manufacturing Support
  • Radiopharmaceutical Manufacturing
  • Medical Device Manufacturing
  • Sterile Manufacturing
  • Sterile Injectable Production
  • Aseptic Processing
  • Cleanroom Operations
  • Automated Manufacturing Lines
  • Process Validation
  • Equipment Qualification
  • Utility Engineering
  • Maintenance Programs
  • Technical Troubleshooting
  • CAPA
  • Corrective and Preventive Actions
  • Deviation Investigations
  • Root Cause Analysis
  • Change Control
  • Risk Assessment
  • Risk Management
  • Continuous Improvement
  • Process Monitoring
  • Data Analysis
  • Technical Writing
  • GMP
  • cGMP
  • Quality Systems
  • FDA 21 CFR 210
  • FDA 21 CFR 211
  • FDA 21 CFR 820
  • ISO 13485
  • EU GMP Annex 1
  • Regulatory Compliance
  • Audit Readiness
  • Manufacturing Operations
  • Technical Transfer
  • Scale Up
  • Lifecycle Management
  • Validation Protocols
  • Documentation Control
  • QA
  • Quality Assurance
  • QC
  • Quality Control
  • Supply Chain
  • Cross Functional Collaboration
  • Project Management
  • Lean Manufacturing
  • Radiation Safety
  • Radioactive Materials Handling
  • Pharmaceutical Manufacturing
  • Combination Products
  • Sterile Fill Finish
  • Excel
  • TrackWise
  • CATSWeb
  • Electronic Document Management Systems
  • Electronic Change Control Systems
  • Equipment Engineering
  • Manufacturing Engineering
  • Process Improvement
  • Commercial Product Support
  • Matrix Organization Experience.

Summary

Process Engineer II 

We are seeking an experienced Process Engineer II to support radiopharmaceutical manufacturing operations. In this role, you will provide technical support to automated manufacturing lines, troubleshoot process and equipment issues, lead deviation investigations and CAPAs, and support process validation, equipment qualification, and continuous improvement initiatives. You will work closely with Manufacturing, Quality, Engineering, and Supply Chain teams to ensure safe, compliant, and efficient production while supporting change controls, technical transfers, and regulatory readiness activities.

The ideal candidate will have a Bachelor's degree in Engineering, Chemistry, or a related technical field, along with experience in medical device, sterile injectable, pharmaceutical, or radiopharmaceutical manufacturing environments. Strong knowledge of cGMP regulations, aseptic processing, process validation, deviation investigations, and quality systems is required. Experience with sterile fill-finish operations, risk management, technical writing, and cross-functional project leadership is highly valued. Experience supporting radiopharmaceutical manufacturing or handling radioactive materials is a plus. This is an excellent opportunity to join a growing organization focused on advancing innovative healthcare technologies in a highly regulated manufacturing environment.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10116144
  • Position Id: 72423
  • Posted 15 hours ago
Contact the job poster
Carl Witham

Carl Witham

Engineering Recruiting Manager @ The Davis Companies
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