Senior Packaging Engineer, Consultant

Pharmatech Associates; San Diego, Northern (CA, KY); Hybrid; USD 130,000 - 180,000; Full time

Job summary

Pharmatech Associates is seeking an experienced Senior Packaging Engineer Consultant to provide project-based packaging expertise and oversight for a Swiss CMO. This remote role requires coordinating with the CMO and internal stakeholders to plan, review, and execute packaging activities.

You will lead packaging activities, review designs, select equipment, and ensure GMP compliance and timely project delivery. Travel to Switzerland is not required.

Qualifications

• Bachelor's degree plus 10 years of relevant packaging experience, senior/SME level.
• Experience overseeing packaging activities at a CMO/CDMO.
• Strong knowledge of packaging processes, equipment, GMP and regulatory expectations.
• Experience with BFS vial packaging and secondary packaging operations.
• Ability to manage external vendors and provide clear technical direction.

Responsibilities

• Provide overall packaging SME leadership and technical oversight of primary and secondary packaging activities.
• Review packaging designs, specifications, and procedures for GMP compliance.
• Identify packaging risks and mitigation strategies with vendors and the CMO.
• Support regulatory filings and responses related to packaging activities.

Skills

Packaging SME

CMO oversight

GMP knowledge

Vial packaging

Vendor management

Regulatory input

Education

Bachelor's degree in packaging

Job description

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world.

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.