Senior Packaging SME - Remote Pharma CMO Lead

Pharmatech Associates, a USP company; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Pharmatech Associates, Inc. seeks an experienced Senior Packaging Engineer Consultant to provide project-based packaging expertise for a Swiss CMO. This is a remote consulting role with no travel required.

You will lead packaging planning, design review, procurement, qualification, and execution across primary and secondary packaging activities. You will work with the CMO and internal stakeholders to ensure compliant, timely, and quality-focused packaging solutions, covering BFS vial packaging,

Qualifications

• Bachelor's degree plus 10 years of relevant packaging engineering experience.
• Experience overseeing packaging activities at a CMO/CDMO.
• Strong knowledge of pharmaceutical packaging processes, equipment, and packaging operations.
• Experience with BFS vial packaging and/or unit-dose packaging processes.
• Experience with foil pouching, cartoning, IFU insertion, sealing, and secondary packaging operations.
• Experience supporting the selection and procurement of packaging equipment and working with equipment suppliers/vendors.
• Strong understanding of GMP, quality systems, and regulatory expectations related to pharmaceutical packaging.
• Demonstrated ability to manage external vendors and CMO relationships from a technical and project oversight perspective.
• Ability to provide clear technical direction and sound recommendations while operating in a consulting/oversight capacity.

Responsibilities

• Provide packaging SME leadership and technical oversight for planning and execution of packaging activities.
• Oversee primary and secondary packaging activities including BFS vials, foil pouching, and cartoning.
• Identify packaging equipment needs and support vendor selection and procurement.
• Provide oversight of packaging equipment specifications, installation, and readiness.
• Ensure alignment with project timelines, quality expectations, and regulatory standards.
• Support investigations, deviations, change controls, and problem-solving activities.
• Provide regulatory input for packaging filings and regulatory responses.
• Participate in project meetings and design reviews as the packaging SME.
• Ensure documentation meets GMP, quality, regulatory, and company requirements.

Skills

Senior packaging expertise

Education

Bachelor's degree + 10 years packaging experience

Job description

Pharmatech Associates, Inc. seeks an experienced Senior Packaging Engineer Consultant to provide project-based packaging expertise for a Swiss CMO. This is a remote consulting role with no travel required.

You will lead packaging planning, design review, procurement, qualification, and execution across primary and secondary packaging activities. You will work with the CMO and internal stakeholders to ensure compliant, timely, and quality-focused packaging solutions, covering BFS vial packaging,