3 jobs in United Consulting Hub
Senior Process Engineer – Aseptic Fill-Finish & Project Lead
Posted 2 days ago
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Job Description
Role: Mid/Senior Process Engineer (Based on Experience)
Duration: 12+ Months
We are seeking a Mid/Senior Process Engineer to support a facility expansion project currently in the design phase. The ideal candidate will have hands-on experience leading projects from design through implementation , with a strong background in aseptic fill-finish manufacturing .
Key Responsibilities:
- Support facility expansion and equipment implementation projects.
- Prepare and manage RFPs , evaluate vendor quotations, and coordinate with external equipment suppliers.
- Conduct design reviews based on internal User Requirement Specifications (URS) .
- Collaborate with cross-functional teams and external vendors throughout the project lifecycle.
- Drive process improvements and ensure successful equipment installation and startup.
Required Experience:
- Proven experience in fill-finish manufacturing is mandatory .
- Hands-on experience with:
- Vial Washers
- Cappers
- Container Closure Integrity Testing (CCIT)
- Automated Syringe Assembly
- Autoclaves
- Experience supporting FAT/SAT activities.
- Strong process engineering and equipment design experience.
- Demonstrated experience managing projects from design through implementation .
- Process improvement and continuous improvement expertise.
Note: This is not a CQV or Validation Engineer role. We are specifically looking for a true Process Engineer with hands-on process design, equipment, and fill-finish manufacturing experience.
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Regulatory Affairs (Program Manager)
Posted 2 days ago
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Job Description
Role :: Regulatory Affairs (Program Manager) Locations :: Multiple Locations Employment Type :: W2 Contract
We are seeking an experienced Regulatory Affairs Program Manager with a strong Medical Device background to lead a global Regulatory Divestiture Program.
MUST HAVE:- Must have significant hands‑on Regulatory experience within Medical Device Industry
- Must have experience doing Regulatory Affairs on a Divestiture Project
- Must have RA Program Management experience
- The Regulatory Separation Plan is 80% complete. This Regulatory Program Manager will confirm the Regulatory Separation Plan and their first main deliverable will be to complete the Regulatory Registration Transfer Strategy / Plan.
- This would include identifying all registrations; coordinating all ownership transfers, amendments, renewals, notifications, and any new submissions.
- Ensure consistent Regulatory Compliance; GMP
- Risk Management – identify gaps and potential risks; create contingency plans
- Continuously document project details and update accordingly within Project Management tracking system
10+ years in Medical Device Regulatory Affairs
Regulatory Divestiture or Separation Projects
Regulatory Program Management
FDA 510(k) and PMA Submissions
Global Regulatory Registrations and Submission Strategy
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Global Medical Device Regulatory Divestiture PM
Posted 2 days ago
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Job Description
United Consulting Hub is seeking an experienced Regulatory Affairs Program Manager with a strong medical device background to lead a global regulatory divestiture program.
The role focuses on confirming the regulatory separation plan, mapping registrations, coordinating ownership transfers, renewals, and new submissions, while ensuring GMP compliance and effective risk management across multiple locations.
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Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.