Qse7

QSE7, a Pennsylvania-based consulting firm, is seeking to hire a detail-oriented Liquids Packaging Engineer to join our team, supporting FDA-regulated pharmaceutical and OTC drug clients. In this role, you will be responsible for planning and executing packaging engineering assignments for liquid drug products, supporting new product development initiatives. You will play a crucial role in developing and maintaining primary and secondary packaging components, container-closure systems, labeling, and fill/dispensing systems for pharmaceutical and OTC liquid formulations while ensuring compliance with FDA and applicable global regulations. This is a hybrid role which will require commuting to the client site in Fort Washington, PA twice a week.

Job Responsibilities:

• Plan and execute liquids packaging engineering assignments under limited supervision, ensuring adherence to cGMP requirements, FDA regulations (21 CFR Parts 210, 211, and 700 series), and applicable federal, state, and local laws, as well as company policies and guidelines.
• Develop and maintain packaging components and container-closure systems (CCS) for pharmaceutical/OTC liquid products, including bottles, vials, pumps, child-resistant closures, seals, and dispensing systems that support new product introductions, technical transfers, cost improvements, and quality and compliance initiatives.
• Collaborate with cross-functional teams (formulation, manufacturing, quality, regulatory affairs) to support liquids packaging initiatives for all brands, aligning with long-term company goals.
• Create and implement short-term programs and strategies related to liquids packaging, including package development, fill-line compatibility, drug facts/prescribing information labeling, and component specifications that align with the team's vision and strategy.
• Lead the development and assessment of essential information to support liquid drug product package development and lifecycle management initiatives, including design requirements, scope definition, packaging and filling equipment solution proposals, risk assessments, test plans, and results analysis.
• Oversee the creation and routing of package development documentation to capture end-to-end project-specific information for pharma/OTC liquid products, ensuring alignment across functions and obtaining necessary approvals. This includes documents such as Package Component Specifications and Package Development Assessment and Plan documents.
• Ensure packaging designs meet child-resistant packaging requirements (Consumer Product Safety Improvement Act) and tamper-evident requirements (21 CFR 211.132) where applicable.
• Stay informed of new and changing FDA and global regulatory requirements related to pharmaceutical/OTC liquid packaging and labeling (including DSCSA serialization requirements), and develop strategies to ensure compliance.
• Conduct knowledge gap assessments and leverage prior knowledge of liquid fill, closure, and container systems in a regulated pharma/OTC environment to inform packaging solutions and improvements.
• Collaborate with suppliers and vendors to source pharma-grade liquid packaging materials and components (bottles, closures, seals, dispensing systems), ensuring quality, compendial compliance, and cost-effectiveness.
• Participate in continuous improvement initiatives related to liquids packaging processes, materials, and technologies, including fill-line efficiency.

Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, or a related field.
• 3 years of experience in packaging engineering, with direct experience in pharmaceutical or OTC liquid drug product packaging required.
• Strong understanding of liquid drug product packaging materials, container-closure systems, design principles, and manufacturing/filling processes within a cGMP environment.
• Working knowledge of FDA regulations (21 CFR 210/211) and global regulatory requirements related to pharmaceutical/OTC liquid packaging and labeling.
• Excellent problem-solving and analytical skills, with the ability to assess risks (e.g., container-closure integrity, stability) and develop effective strategies.
• Strong project management skills with the ability to manage multiple assignments simultaneously.
• Excellent communication skills, both written and verbal, with the ability to work collaboratively in a cross-functional team environment.
• Proficient in relevant software tools (e.g., CAD, packaging design software, MS Office Suite).

About QSE7 - Founded in 2016, QSE7 offers innovative and specialized Information Technology (IT) and Consulting services to FDA-regulated life sciences companies. Our areas of focus include program/project management, process analysis, automated business process improvements, data analytics and reporting, and implementation of IT solutions based on Microsoft technologies, such as Excel, MS Teams, SharePoint, Power BI and Power Automate. We strive to bring automation and efficiency to our clients' processes by providing high-quality and intuitive solutions in an efficient, comprehensive manner.

Founded in 2016, QSE7 provides specialized IT and consulting services to FDA‐regulated life sciences companies. Our core capabilities include process optimization, digital transformation, and implementation of Microsoft‐based solutions across quality, manufacturing, and business operations.

We focus on delivering high-impact, scalable solutions that improve efficiency, ensure compliance, and enable data-driven decision-making.