Manufacturing Specialist (Packaging Operations)

Role Summary :

• Acts as the primary operations contact, overseeing manufacturing process design, documentation, and compliance. Serves as SME for technical content, managing risk assessments, change controls, and regulatory requirements. Collaborates with cross-functional teams and Capital Project stakeholders to ensure timely execution of automated packaging lines.

Day to Day Responsibilities :

• Support Manufacturing Operations : Act as the primary contact for operations, troubleshooting issues, and ensuring smooth production.
• Process & Documentation Management : Develop, review, and approve SOPs, Work Instructions, Risk Assessments, and Change Control records to maintain compliance and accuracy.
• Cross-Functional Collaboration : Work with Engineering, Quality, Supply Chain, and Tech Transfer teams to align on project execution, documentation, and operational readiness.
• Project Execution & Risk Management : Partner with the Capital Project team to manage schedules, budgets, risks, and overall project progress.
• Training & Process Readiness : Assist in developing training materials and ensuring teams are prepared for packaging procedures and equipment operations.
• Regulatory & Quality Compliance : Participate in risk assessments, support regulatory inspections, and ensure all manufacturing processes meet compliance standards.
• Continuous Improvement : Identify opportunities for process optimization, efficiency enhancements, and operational excellence initiatives.
• Reporting & Communication : Provide updates on project status, document progress, and align with stakeholders on priorities and action items.

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.

Hiring Manager Intake Notes :

• What is the working environment for this role? IE office based, lab based, manufacturing floor? Office based, manufacturing floor based
• What are the exact shift hours / schedule the contractor will be working / reporting? Regular shift hours (8am-5pm) Monday - Friday.
• Do you have a preference on time zone? The time zone would be Eastern Standard Time (EST)
• What type of qualities / characteristics are you looking for in candidates to work best with your team? Great Team player, Excellent communication qualities and critical thinking skills.
• When reviewing resumes, what stands out to you when looking for the right applicants? Relevant Experiences, Innovative / creative solutions, and proactive approaches.
• What is your minimum education and years of work experience you think it most suitable for this role? Bachelors and 3-5 years of experience in relevant areas.

Basic Qualifications

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

What we are looking for :

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