Remote Senior Packaging SME for CMO Oversight

Pharmatech Associates, a USP company; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Pharmatech Associates, Inc. is seeking an experienced Senior Packaging Engineer Consultant to provide project-based packaging leadership for a CMO in Switzerland.

This remote role requires coordinating packaging activities, ensuring regulatory compliance, and delivering on project timelines. As the packaging SME, you will oversee design reviews, equipment procurement, vendor management, and packaging operations such as BFS vial packaging, cartoning, IFU insertion, and sealing, while maintaining

Qualifications

• Bachelor's degree plus 10 years of packaging engineering or pharmaceutical packaging experience.
• Experience overseeing packaging activities at a CMO/CDMO.
• Strong knowledge of GMP, quality systems, and regulatory expectations related to pharmaceutical packaging.
• Experience with BFS vial packaging and/or secondary packaging operations.

Responsibilities

• Provide packaging SME leadership and oversight of primary and secondary packaging activities.
• Identify, select, and procure packaging equipment required for the project.
• Provide expert oversight of packaging equipment specifications, vendor interactions, installation, and readiness.
• Provide vendor oversight to ensure alignment with project requirements, timelines, quality expectations, and standards
• Review packaging designs, processes, specifications, procedures, and documentation.
• Identify packaging risks and mitigation strategies; support investigations and change controls.
• Provide regulatory input for filings and responses related to packaging activities.
• Participate in project meetings, design reviews, and CMO/vendor meetings as packaging SME.
• Ensure packaging activities are documented and aligned with GMP and regulatory requirements.

Skills

Packaging SME

CDMO oversight

GMP compliance

Regulatory support

BFS packaging

Cartoning

IFU insertion

Sealing

Vendor management

Equipment procurement

Education

Bachelor's degree in a related field

Job description

Pharmatech Associates, Inc. is seeking an experienced Senior Packaging Engineer Consultant to provide project-based packaging leadership for a CMO in Switzerland.

This remote role requires coordinating packaging activities, ensuring regulatory compliance, and delivering on project timelines. As the packaging SME, you will oversee design reviews, equipment procurement, vendor management, and packaging operations such as BFS vial packaging, cartoning, IFU insertion, and sealing, while maintaining