Senior Manufacturing Engineer

Overview

On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)
10% Travel

Skills

automated filling & packaging equipment
IQ/OQ/PQ
cGMP
Manufacturing Engineer
automation
design transfer
FDA regulations

Job Details

Senior Manufacturing Engineer High-Speed GMP Filling & Packaging

We re seeking a hands-on Senior Manufacturing Engineer with proven experience in high-speed GMP manufacturing involving automated filling and packaging equipment. This role focuses on installing, starting up, and optimizing equipment to drive operational excellence.

Key Responsibilities:

  • Define specifications for new equipment and packaging components, aligning production capabilities with business goals.

  • Lead installation, startup, and qualification (IQ/OQ/PQ) of automated filling and packaging systems.

  • Drive initiatives to reduce downtime, improve throughput, and optimize manufacturing processes.

  • Support process design, scale-up, validation, and troubleshooting in a GMP environment.

  • Develop and maintain manufacturing documentation including SOPs, batch records, and change requests.

  • Lead cross-functional project teams and manage timelines to meet key milestones.

  • Ensure compliance with cGMP, FDA, and ISO standards.

Qualifications:

  • Bachelor s in Engineering (or related field) with 5 6 years of relevant GMP manufacturing experience (Master s with 4+ years).

  • Strong background in automated filling & packaging equipment and equipment qualification (IQ/OQ/PQ).

  • Experience with adhesive bonding, microdispensing, injection molding, and surface treatments (plasma/CO cleaning) preferred.

  • Knowledge of automation, design transfer, and FDA regulations.

  • Self-starter with excellent project leadership and communication skills.

  • Experience in pharmaceutical, medical device, or diagnostics manufacturing. Material science knowledge is a plus.

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