Senior Packaging Engineer

Senior Packaging Engineer
PharmEng Technology is currently seeking a Senior Packaging Engineer to assist our team for projects in Cambridge, MA. The position is available immediately conditional of a successful interview.
Job Description:
  • Manage development and maintenance of global packaging standards, policies, and best practices to help ensure technical and regulatory compliance.
  • Define or contribute defining set of procedures, technical work instructions and other elements of Packaging Development system.
  • Work with Corporate Quality to help understanding and translate current regulations, guidance and standards.
  • Manage testing, inspection, and data collection and analysis for engineering testing or qualification of primary, secondary, and tertiary packaging at internal or external test facilities which includes the planning, scheduling, budgeting, and organization of test products, materials, and services.
  • Help maintain internal test lab and all equipment and activities within which includes helping maintain lab accreditation and helping organize maintenance and calibration of equipment and instrumentation as necessary.
  • Identify opportunities to stop non-value added activities, as well explore potential opportunities to partner with outside vendors.
  • Lead or oversee the design, development, and testing of high visibility, complex packaging projects from initiation and planning at the program level into ideation and conceptual design through design/technology transfer and commercial implementation readiness. 
  • Design and development includes identification of packaging design or user requirements, research and selection of packaging materials, suppliers, and technologies, and the test artwork development process.
  • Lead or oversee packaging lifecycle changes, initiatives, process improvements, etc.
  • Oversight (formal or informal) may include junior or entry level engineers, support staff engineers, co-op/intern students, etc.
  • Author or support technical documentation related to packaging for design or user requirements, design verification, design/technology transfer, qualification or validation protocols and reports, specifications, technical drawings, etc.
  • Author or support assessments for comparability, manufacturability, suitability and risk.
  • Support business initiatives such as implementing tamper evidence and chemical taggant technology and packaging sustainability to help reduce the environmental impacts of packaging as well as regulatory rulings such as serialization or track-and-trace for drug quality and supply chain security and Unique Device Identification (UDI) designed to identify devices through distribution and use and support other relevant department initiatives.
  • Provide technical support and help conduct investigations for issues related to packaging.
  • Assume responsibilities for all necessary quality systems for change controls, vendor change notifications, technical product complaints, deviations, exceptions, and CAPAs related to packaging.
  • Author or support documentation management for global standards and policies as well as standard operating procedures, test methods, and work instructions.
  •  Participate in internal and external cGMP, quality, and technical audits as necessary.
 Job Requirements:
  • Bachelor’s degree in a science / engineering field.
  • 10+ years packaging related experience.
  • 5+ years of experience within the pharmaceutical, biotechnology, medical device, food or health care industry preferred.
  • Strong understanding of cGMP environment. Working knowledge of packaging related standards and regulations for ASTM, CPSC, EFPIA, EMA, FDA, GS1, ICH, ISO, ISPE, ISTA, PDA, USP, and WHO.
  • Must have experiences developing policy and procedures within the Packaging Development framework.
  • Must be comfortable working independently within a matrix organization.
  • Experience working with external suppliers and contractors.
  • The ability to manage multiple projects in a fast paced, dynamic environment.
  • Excellent written and verbal communication and project management skills.
  • Experience with packaging materials such as rigid and flexible plastics, glass, films and foils, pressure sensitive labels, tamper seals, tape, and bags, paperboard, paper and plastic corrugate, foam, etc.
  • Knowledge of packaging related standards and regulations and regulatory and compliance requirements for device design controls and combination products.
  • Understanding of patient centered design and Human Factors Engineering experience.
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
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