Manufacturing Specialist

Description :

• Primary point of contact to support operations and the organization through planning, designing, creating manufacturing processes.
• Serve as the Subject Matter Expert (SME) for documentation, specifically responsible for initiating, revising, and / or approving technical content and manufacturing procedures (SOPs, WIs, Risk Assessments, Vendor URS, Protocols & Reports) to ensure all procedures reflect equipment design, regulatory requirements, and quality standards.
• Collaborate with the Capital Project team to develop and align on the project schedule and budget, managing the work plan, risks, and overall execution throughout the project lifecycle
• Provide impact and risk assessments for Change Control Review Board (CCRB) records as the change control owner. Contribute to equipment quality risk assessments (QRAES) and ensure proper manufacturing design and controls are in place.
• Collaborate with key cross-functional teams including, but not limited to, Engineering, Quality, Supply Chain, Product Development, Tech Transfer and NPI, and External equipment suppliers to ensure timely and accurate delivery of automated, high speed packaging manufacturing lines.
• Support the development of training materials for packaging procedures and equipment operations to ensure readiness for the packaging process.
• Actively participate in workshops pertaining to technology transfer / NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Manufacturing SME and point of contact to participate in regulatory inspections / audits.

Top 3 Must Have Skill Sets :

Packaging Operations & Process design, Technical and Engineering Design, Project management Skills

Basic Qualifications :

Doctorate degree OR master’s degree and 3 years of experience OR bachelor’s degree and 5 years of experience OR associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.

Day to Day Responsibilities :