Engineer Senior, Biotech Sterilization; JP

Engineer Senior, Biotech Sterilization

Location:

Cambridge, MA. 02138

Business Unit:
Manufacturing Science and Technology

Employment Type:

Contract

Duration: 1+ year with likely extensions and/or conversion to a permanent position.

Rate: $44 - $50/hour W2

The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for client's portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs.

The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.

• Sterilization experience
• Qualification/ quality experience
• Commercial process lifecycle management

• Support/ lead process development and commercialization of gas sterilization processes of combination products
• Coordinate/ lead manufacturing site requirements to support sterilization requirements
• Support the design control process and qualification of primary components
• Support/ lead tech transfer projects for combination products
• Support/ lead the development and operational improvements with key primary component suppliers
• Support development of characterization methods for mechanical and physical properties of primary components
• Support on-going deviation/ CAPA and change control
• Support/ lead client's supplier/ raw materials sterility assurance assessments
• Collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
• Drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• 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 read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Strong problem-solving skills
• Capability to advance multiple projects in a fast paced environment
• Strong oral and written communication skills, decision making, presentation, and organization skills

Phone and In Person

Supplement additional workload on team