Senior Scientist, Sterility Assurance at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Mar, 26

Salary

0.0

Posted On

24 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sterility Assurance, Aseptic Processing, Sterile Product Manufacturing, Microbiological Testing, Regulatory Compliance, Communication Skills, Collaboration Skills, Terminal Sterilization Methods, Contamination Control, Quality Systems, Product Validation, Risk Assessments, Internal Audits, Technical Documentation, Troubleshooting, Project Development

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Support sterility assurance activities for product development, manufacturing processes, and contamination control programs. Assist in evaluating sterilization modality options and contribute to product validation activities, including documentation and data review. Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure sterility assurance requirements are understood and incorporated into project activities. Participate in internal audits, regulatory inspections, and risk assessments by preparing data, documentation, and technical rationale. Apply foundational knowledge of terminal sterilization methods (EO, gamma, moist heat) to support troubleshooting and product development needs. Contribute to project teams by providing sterility assurance input and ensuring requirements are addressed throughout development. Support Global Sterility Assurance network projects and priorities. Required: Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biomedical Engineering, or related field (or equivalent experience). 2-4 years of experience in sterility assurance, aseptic processing, or sterile product manufacturing. Foundational knowledge of terminal sterilization methods (EO, gamma, moist heat) and basic microbiological testing principles. Familiarity with relevant global regulatory expectations for sterility assurance (e.g., FDA, ISO, ICH). Strong communication and collaboration skills in team-based environments. Experience working in a ISO 13485 Quality System. Master's degree in a scientific or engineering discipline. Experience supporting new product development or process changes in a regulated industry. Understanding of contamination control practices in medical device or pharmaceutical manufacturing. Exposure to audits or regulatory inspections involving sterility assurance topics.

Responsibilities

Support sterility assurance activities for product development and manufacturing processes. Collaborate with various teams to ensure sterility assurance requirements are incorporated into project activities.