Senior Scientist, Microbiological Quality and Sterility Assurance (MQSA)

Johnson & Johnson•Palm Beach Gardens, FL

20d

About The Position

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Johnson and Johnson is recruiting for a Senior Scientist, Microbiological Quality and Sterility Assurance (MQSA) , to be located at a DePuy Synthes Manufacturing or Product Development Site in Warsaw, IN, Raynham, MA, or Palm Beach Gardens, FL . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Senior Scientist is responsible for supporting the end-to-end contamination control and sterility assurance practices for the development of new products and/or sustainment of commercial products within Global Orthopedics.

Requirements

Bachelor of Science or equivalent university degree in Microbiology, Biology, Engineering or related discipline is required.
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.

Nice To Haves

An advanced degree, such as a Master of Science (MS) or PhD in Microbiology, Biology, Engineering or related discipline is 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.).

Responsibilities

R&D – 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
Plan – Provide input into the selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)
Source – 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.
Make – 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
Deliver – 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
External Influencing – Provide site input to the J&J representatives of industry and standards associations (e.g., AAMI, ISO, AORN), influencing regulations and standards
Internal Influencing – Participate on the J&J Sterility Assurance Councils.

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year