Proclinical is currently recruiting for a Thermal Packaging Engineer with a biotechnology company located in Cambridge, MA. The Packaging Engineer will serve as the compliance subject matter expert on all packaging related to cold chain shipping, to include both warm and cold weather profiles. The incumbent is responsible to adhere and support Quality Management System and GMP Compliance Programs to assure product integrity and compliance with regulatory guidelines and internal/global standards and procedures. This person will interact Global Supply Chain, PDQ, QC, Commercial Quality, Device Quality, GEQ CMO Leads, Technical Development, Packaging Engineering, Device Development, and Regulatory Affairs to ensure on-time qualification and validation of ship solutions to support commercial launch of Biogen's late phase assets. This person may also write and revise SOPs (Standard Operating Procedures) as it relates to ship qualification activities and GDPs and may be asked to assist in deviations management, CAPAs, change controls, investigations, and risk assessments using scientific principles as needed.
Job Responsibilities:
- Develop quality strategy and ensure compliance in the development of thermal shipping systems
- Perform technical assessment, risk assessments and studies
- Review and approve technical reports, validation protocols and reports for DQs/OQs/PQs, manuals, specifications, and SOPs
- Review and perform QA approval on ship qualification relevant documents, Deviations, CAPAs, Change-Controls as needed and as appropriate
- Participate in cross-functional teams to develop shipping solutions that meet our expanding commercial pipeline
- Apply engineering and project-management principles to support the development and qualification of thermal packaging systems based on ASTM and ISTA Brochure 20 & 7D/7E Standards
- Develop comprehensive and sustainable shipping controls processes and methodology, including but not limited to, package configuration options, transport lane analysis, package design change and shipping configuration change impact analysis, temperature control validation, time & conditions transit tracking
- Other job duties as assigned
Skills and Requirements:
- BS Degree in Packaging Engineering or Packaging Science
- 1-2 years of experience in thermal packaging
- ISTA 7E Certified Thermal Professional preferred
- Work experience in the cold chain packaging industry preferred. Specifically, thermal packaging design and testing according to ASTM and ISTA Brochure 20 & 7D/7E Standards
- Demonstrated success in validation, manufacturing or supply-chain areas with strong fundamental knowledge on thermal packaging systems and packaging engineering and/or validation preferred
- Demonstrated organizational, project management, technical problem-solving and (written & verbal) communication skills
- Demonstrated skills in technical presentation, issue organization, and analytical problem solving
- Demonstrated ability to successfully manage a multitude of tasks concurrently
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
- Good understanding of the underlying principles and concepts of the release process, and a general understanding of the manufacturing and QC steps
- Operations experience in Quality Assurance, Quality Control, and Manufacturing including batch record review
- Demonstrated ability to consistently meet or exceed project deadlines.
- The critical aspects of this role will be focusing on cold chain packaging design and global logistics system & processes. The successful candidate will have hands on expertise developing packaging systems and protocols on a global scale. In this role the person is responsible for ensuring all aspects of compliance for Biogen's qualification of cold-chain shipping solutions. This position requires partnership with Global Supply Chain, PDQ, QC, Commercial Quality, Device Quality, GEQ CMO Leads, Technical Development, Packaging Engineering, Device Development, and Regulatory Affairs to implement new processes and manage changes. This position participates in the development of a product delivery system to support our Cell Banks, RSMs, API, Drug Substance, Intermediates, Drug Product, Device and Finished Product. The candidate is accountable for ensuring all aspects of compliance towards the implementation, sustainment, improvement, and expansion of ship qualification and end to end cold chain management for our products. There is no budgetary responsibility for this role.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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