Senior Scientist, Microbiological Quality and Sterility Assurance (MQSA) Full-time

Senior Scientist, Microbiological Quality And Sterility Assurance (Mqsa)

Johnson & 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.

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.

Key Responsibilities:

This individual will be responsible for activities such as, but not limited to, the following:

• 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.

Qualifications

Education:

• 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.

Experience and Skills:

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.

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.).

Other:

• The work environment is primarily in a local or remote office, and may require periodic interactions with manufacturing. The individual must be able to comply with established safety procedures and policies to maintain a safe working environment to ensure compliance with J&J environmental policies.
• Up to 10% travel may be required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is:

$92,000.00 – $148,350.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits