Jobs via Dice
Overview
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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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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