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The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions that meet user requirements for Client’s portfolio of therapeutic products, from concept through commercial entry. The individual advances technical programs by defining design requirements, identifying and realizing technical solutions, authoring test methods and reports, and conducting technical analyses to progress programs. The successful candidate establishes well-supported insights for development, clinical, and commercial stage solutions to serve user needs and pipeline requirements, utilizing various program tools, design characterization, verification methods, and design reviews. S/he ensures that performance and quality targets are met and helps identify and mitigate technical risks.
Responsibilities include but are not limited to:
Support or lead process development and commercialization of gas sterilization processes of combination products.
Coordinate or lead manufacturing site requirements to support sterilization processes.
Support the design control process and qualification of primary components.
Support or lead technology transfer projects for combination products.
Support or lead development and operational improvements with key primary component suppliers.
Support development of characterization methods for mechanical and physical properties of primary components.
Assist with ongoing deviation/ CAPA and change control processes.
Support or lead sterility assurance assessments of Client suppliers and raw materials.
Collaborate extensively with internal and external stakeholders such as manufacturing, suppliers, quality, regulatory, and senior management.
Drive and influence key opinion leaders through technical papers, presentations, and conference attendance.
Preferred Qualifications:
3+ years in ethylene oxide or other gas sterilization processes.
3+ years industry experience in sterility assurance of combination products.
3+ years in ethylene oxide, moist heat, and/or vaporized hydrogen peroxide sterilization.
Ability to analyze and interpret business periodicals, journals, technical procedures, and regulations.
Strong problem-solving skills.
Capability to manage multiple projects in a fast-paced environment.
Excellent oral and written communication, decision-making, presentation, and organizational skills.
Basic Qualifications:
Doctorate OR Master’s degree with 3+ years of experience OR Bachelor’s degree with 5+ years of experience OR Associate degree with 10+ years of experience OR High school diploma/GED with 12+ years of experience.
Top 3 Must-Have Skill Sets:
Qualification/quality experience
Management of the product/process lifecycle
Day-to-Day Responsibilities:
Support or lead process development and commercialization of gas sterilization processes.
Coordinate or lead manufacturing site requirements for sterilization.
Support design control and qualification of primary components.
Support or lead tech transfer projects for combination products.
Support or lead development and operational improvements with suppliers.
Develop characterization methods for primary components.
Assist with deviation/ CAPA and change control activities.
Support sterility assurance assessments.
Collaborate with stakeholders across functions.
Engage with key opinion leaders through publications and conferences.
Seniority level Mid-Senior level
Employment type Contract
Job function Biotechnology Research and Staffing and Recruiting
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