Downstream Process Engineer
Contract W2
Contract Independent
12 Months
No Travel Required
On-site
Depends on Experience
Fitment
Dice Job Match Score™
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Job Details
Skills
- downstream process engineering
- manufacturing support experience
Summary
Primary Responsibilities
The primary objective of this position is to ensure manufacturing equipment is operationally ready to support production. Approximately 50% of the role involves hands-on troubleshooting and resolving equipment or process-related issues on the manufacturing floor.
Responsibilities include:
• Verifying equipment readiness, including preventive maintenance, operational checks, and manufacturing recipe functionality.
• Troubleshooting downstream processing equipment and resolving technical issues impacting manufacturing.
• Investigating equipment-related deviations, identifying root causes, and supporting corrective actions.
• Authoring and revising Operational Design Documents (ODDs), Operational Qualification (OQ) documentation, and equipment-related SOPs.
• Reviewing equipment records, technical documentation, and historical investigations to identify information and resolve issues.
• Collaborating with Manufacturing, Facilities, Maintenance, Quality, Validation, and Document Control teams.
• Providing occasional support to upstream manufacturing operations as needed.
Key Technical Requirements
• 5+ years of downstream process engineering experience in biopharmaceutical manufacturing.
• Strong hands-on equipment troubleshooting and manufacturing support experience.
• Experience with TrackWise, particularly equipment-related deviations and investigations.
• Strong GMP documentation and technical writing skills.
• Familiarity with KNEAT.
• DeltaV, UNICORN, and Veeva experience are additional advantages.
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: 945466
- Posted 8 days ago
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