Senior Packaging Engineer, Consultant

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

Location San Francisco, CA

Full Remote

Posted Sep 9, 2026

Position Overview

We are seeking an experienced Senior Packaging Engineer Consultant to provide project-based packaging expertise, leadership, and oversight for our client's Contract Manufacturing Organization (CMO) in Switzerland. This is a remote consulting opportunity; travel to Switzerland is not required. The consultant will serve as the primary packaging subject matter expert (SME), overseeing the planning, design review and development, procurement, qualification, and execution of packaging activities at the CMO.

The successful candidate will work closely with the CMO and internal project stakeholders to ensure packaging activities are appropriately planned, technically sound, compliant with applicable regulatory requirements, and executed according to project timelines and quality expectations.

Key Responsibilities

• Provide overall packaging SME leadership and technical oversight including planning and execution of primary and secondary packaging activities, such as:
  • Single-unit punch-out processes for separating individual BFS vials
  • Active and buffer unit foil pouching
  • Secondary packaging activities, including:
    • Cartoning
    • IFU (Instructions for Use) insertion
    • TE seal application
    • Other packaging operations as required by the project
• Provide SME support for the identification, selection, and procurement of packaging equipment required for the project
• Provide expert oversight of packaging equipment specifications, vendor interactions, installation, and readiness, as appropriate
• Provide overall vendor oversight and packaging-related support, ensuring vendors and the CMO remain aligned with project requirements, timelines, quality expectations, and technical standards
• Review packaging designs, processes, specifications, procedures, and documentation as needed
• Identify potential packaging risks, technical issues, and project constraints and provide recommendations and mitigation strategies
• Support packaging-related investigations, deviations, change controls, and problem-solving activities, as needed
• Provide technical input and support for regulatory filings and regulatory responses related to packaging activities, as required
• Participate in project meetings, design reviews, technical discussions, and CMO/vendor meetings as the packaging SME
• Ensure packaging activities are appropriately documented and aligned with applicable GMP, quality, regulatory, and company requirements
• Provide expert guidance to the CMO as it plans and executes packaging activities through project milestones and commercial/clinical readiness, as applicable

Qualifications & Experience

• Bachelor's degree plus 10 years of relevant packaging engineering or pharmaceutical packaging experience, with significant experience in a senior or SME capacity
• Demonstrated 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 comparable unit-dose pharmaceutical packaging processes strongly preferred
• Experience with foil pouching, cartoning, IFU insertion, sealing, and other 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 make sound recommendations while operating in a consulting/oversight capacity

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.