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Posted: Tuesday, June 13, 2017 11:06 AM

Job Description:/h3:
Sr Principal Microbiologist
Bachelors Degree in Biology, Microbiology, or closely related life science; Masters Degree in a technical discipline is preferred.
Ensure newly designed products are cleaned and appropriately packaged, as well as they are properly sterilized to the appropriate sterility assurance level. Act as subject matter expert (SME) in areas such as parts and facilities cleaning, cleanroom operations, sterilization, and related testing. Work to make sure that the biocompatibility of products using industry guidelines and advanced testing technologies is acceptable. Work closely with operations and research groups to develop new products and lead continuous quality improvement initiatives. Lead and complete projects with minimal supervision.

Necessary interpret ISO, AAMI, USP, ANSI, EPA, EU and related guidelines throughout all aspects of manufacturing from design, manufacturing, development, and launch of innovations that are strategically important to the business.
* Demonstrated ability to work cross:functionally with all groups within the site, within the company, and external to the company.
* Demonstrated ability and creativity to analyze, solve problems, troubleshoot, and organize priorities.
* Demonstrated interpersonal communication skills.
* Demonstrated ability to be a positive, energetic team player, and an advocate for product excellence and quality.
* Demonstrated ability to be results:oriented, a quick learner, and demonstrated success in responding to the urgent needs of the team ensuring all deadlines are met.
* Demonstrated ability to mentor microbiologists and scientists.
* Demonstrated ability to sustain exceptional performance and / or have more experience in a large role.
* Demonstrated ability to present scientific data in a meaningful way to various audiences with varied levels of subject understanding.
* Demonstrated ability to lead a large team toward a common goal and obtain timely and satisfactory results.
* Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments.
* Keep current with sterility assurance and sterilization standards as well as advances in microbiology, validation, and testing equipment.
* Author and review Technical Reports and Technical Assessments. Lead non:conformance and CAPA investigations and resolution.
* Actively lead and support new product development activities as they relate to cleaning, sterilization, and testing.
* Lead in the improvement of the manufacturing processes for products as they relate to cleaning, sterilization, and testing.
* Lead in the development, review and approval of sterilization process and equipment
validation/qualifications (IQ, OQ and PQ).
* Be the SME and point of contact for suppliers and for in:house process development, quality issues and process improvements for assigned projects.
* Participate as a supplier SME for any appropriate audits, including contract testing laboratories, contract sterilization companies, and other related activities.
* Support product transfers to other plants/facilities.
* Review/approve nonconforming material and system documentation.
* Act as a mentor to others.
* Serve as a team expert in cleanrooms, environmental monitoring, sterilization, and associated microbiological testing.
* Teach others the techniques and processes that are required to work as a team member.
* Foster healthy working relationships with the immediate and expanded teams, focusing on positive results and Q12 survey improvements.
* Participate in or lead continuous (breakthrough) improvement activity and process re:engineering projects.
* Ability to successfully host and conduct microbiology:
* 13+ years of applied medical device or pharmaceutical microbiological or biological testin


• Location: North Jersey

• Post ID: 38117743 newjersey is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017