About the Company
Our client is a global leader in healthcare innovation, dedicated to improving lives through advanced medical technologies and high-quality products. The organization fosters a collaborative, science-driven environment focused on quality, innovation, and continuous improvement.
Role Description
We are seeking an experienced Staff Scientist to lead microbiological quality and sterility assurance activities across product development and manufacturing operations. This role will provide technical expertise in sterilization validation, aseptic processing, contamination control, and regulatory compliance while partnering closely with Quality, R&D, Manufacturing, and Regulatory Affairs teams.
Responsibilities
- Support New Product Introductions (NPI), including validation activities, protocol/report writing, and regulatory alignment.
- Lead sterilisation and aseptic processing validations for new products, manufacturing sites, and external partners.
- Drive sterility assurance, contamination control, microbiology, and process improvement initiatives across the product lifecycle.
- Support packaging, cleanroom, environmental monitoring, water systems, and manufacturing process validation activities.
- Provide technical expertise for investigations, CAPAs, audits, regulatory inspections, and compliance programs.
- Collaborate with R&D, Quality, Manufacturing, Regulatory Affairs, and external partners to ensure product quality and patient safety.
- Support supplier qualification, change controls, business continuity planning, and long-term sterility assurance strategies.
Requirements
- Bachelor's degree in Microbiology, Biology, Engineering, or a related field (Master's/PhD preferred).
- 8+ years of experience in the medical device or pharmaceutical industry within GMP/ISO-regulated environments.
- Strong expertise in microbiology, sterility assurance, aseptic processing, and sterilisation validation.
- Experience with sterilisation technologies including EO, Gamma, E-Beam, Heat, and Aseptic Processing.
- Proven experience in investigations, CAPA management, audits, and regulatory compliance.
- Excellent communication, stakeholder management, and problem-solving skills.
- Proficiency in Microsoft Office and relevant analytical software.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
58181
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Kalyan Raj
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