Lead Process Engineer, Devens, MA- Onsite

Harvard, MA, US • Posted 11 hours ago • Updated 11 hours ago
Contract Corp To Corp
Contract Independent
Contract W2
1 Year
No Travel Required
On-site
Depends on Experience
Fitment

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Job Details

Skills

  • Validation experience
  • CIP / SIP

Summary

Lead Process Engineer
This role requires the ability to be on-site, Devens, MA

Responsibilities:
•    Lead/Provide technical support for CIP/SIP, ensuring processes operate safely, efficiently, and in compliance with cGMP regulations
•    Lead or support process improvement and scale-up projects
•    Conduct process investigations, identify root causes, and implement corrective/preventive actions to resolve manufacturing issues
•    Develop and optimize process parameters to achieve consistent product quality and yield
•    Prepare and review process documentation including batch records, SOPs, validation protocols/reports, and change control documents
•    Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, and Production) to ensure successful technology transfer and process validation
•    Support equipment qualification and process validation activities for new or modified equipment/processes
•    Analyze production data, generate reports, and recommend process or equipment improvements to enhance performance and efficiency
•    Ensure compliance with all safety and regulatory requirements within the manufacturing environment
Requirements:
•    Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
•    7-10 years of relevant Validation Experience within pharma / biologics
•    Minimum 5 years of Cleaning Validation experience to include:
1. Hands-on experience taking rinse and swab samples and performing visual inspection
2. Experience developing CIP and SIP cycles for process piping, transfer panels, and bioreactors
3. Experience developing load patterns for autoclaves and parts / glass washers
4. Experience with Delta V automation for CIP / SIP
5. Hands on experience executing Riboflavin studies
•    Experience using Ellab ValSuite Pro and ValGenesis systems preferred

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: 91173678
  • Position Id: 8974155
  • Posted 11 hours ago
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