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Senior Engineer

Cambridge, MA 02138

Posted: 03/07/2025 Employment Type: Contract Job Category: Scientific Job Number: 617843 Is job remote?: No Country: United States

Job Description

Target PR Range: 37-47/hr
*Depending on experience

The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for 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.

Responsibilities include but are not limited to:
a) support/ lead process development and commercialization of gas sterilization processes of combination products
b) coordinate/ lead manufacturing site requirements to support sterilization requirements
c) support the design control process and qualification of primary components
d) support/ lead tech transfer projects for combination products
e) support/ lead the development and operational improvements with key primary component suppliers
g) support development of characterization methods for mechanical and physical properties of primary components
h) support on-going deviation/ CAPA and change control
i) support/ lead supplier/ raw materials sterility assurance assessments
j) collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
k) drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences

Preferred Qualifications
a) 3+ years in ethylene oxide or other gas sterilization processes
b) 3+ years industry experience in sterility assurance of combination products
c) 3+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilization
d) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
e) Strong problem-solving skills
f) Capability to advance multiple projects in a fast paced environment
g) Strong oral and written communication skills, decision making, presentation, and organization skills

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.