Johnson & Johnson MedTech · 2 hours ago
Senior Scientist, Microbiological Quality and Sterility Assurance (MQSA)
Raynham, MA
Full-time
Onsite
Mid, Senior Level
$92K/yr - $148K/yr
4+ years expJohnson & Johnson MedTech is dedicated to healthcare innovation and is seeking a Senior Scientist in Microbiological Quality and Sterility Assurance. The role involves supporting contamination control and sterility assurance practices for new and commercial products within Global Orthopedics.
Hospital & Health Care
Responsibilities
Provide input for the following for increasing complexity projects: Design for cleanability, Design for decontamination, Design for sterilizability
Drive selection of sterilization modality, validation approaches and validation of the sterilization process
Generate sterilization product adoptions
Support the regulatory approval of sterile and non-sterile new products, including internal research & development products, new acquisitions, and strategic partnerships
Support the implementation of new innovations in the areas of contamination control, terminal sterilization, and reprocessing, to include such activities as participating in the development of new products
Provide input into the selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)
Provide sterility assurance and contamination control support for due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J
Provide sterility assurance and contamination control for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are externally manufactured
Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint
Provide input for the design of critical water and air systems and the design of controlled environments and cleanliness control strategies
Provide sterility assurance and contamination control support for supplier audits
Provide sterility assurance and contamination control support to strategic MAKE initiatives
Provide input into process risk assessments related to product cleanliness and sterility assurance
Lead non-conformance/CAPA pertaining to product cleanliness and sterility assurance
Work with internal and external laboratories to support sterility assurance testing requirements. Assure implementation of laboratory testing requirements for cleanliness and sterility assurance
Provide support to internal and external audits
Support the ongoing initiatives regarding the validation and improvement of primary non-sterile and sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled products to the patient and/or consumer
Provide site input to the J&J representatives of industry and standards associations (e.g., AAMI, ISO, AORN), influencing regulations and standards
Participate on the J&J Sterility Assurance Councils
Qualification
Required
Bachelor of Science or equivalent university degree in Microbiology, Biology, Engineering or related discipline is required
An advanced degree, such as a Master of Science (MS) or PhD in Microbiology, Biology, Engineering or related discipline is preferred
A minimum of 4 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment
Demonstrated competency in terminal sterilization, Reprocessing, and microbiological contamination
Demonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat)
In a supervisory, coaching, mentoring and/or influencing capacity
Proven track record on monitoring and troubleshooting process non-conformances and out of specification test results and providing resolution to issues by a robust CAPA process across multiple regions
Proven track record on trouble shooting microbiological, aseptic processing and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via a robust CAPA process
Strong knowledge of standards including EU, USA and ISO
Excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area
Demonstrated ability to work in a collaborative/teamwork environment is required
Independent organizational and time management skills
Team player with a customer focus
Competent in using computer software such as Excel, Word and PowerPoint, and analytical software
Preferred
Experience conducting technical assessments of in-house and external manufacturing and terminal sterilization
Experience in interacting with Auditing Bodies (e.g. FDA, EU, etc.)
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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