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Highly skilled and experienced Sr. Scientist to oversee and manage the day-to-day operations activities of Biological Indicators (BI) production lab. The successful candidate will be responsible for leading activities related to spore culture production, ensuring the highest standards of quality and efficiency. This role requires a strong background in microbiology, experience in spore culture techniques, and the ability to manage teams, activities, and projects in a fast-paced production environment.

Duties and Responsibilities

+ Lead day-to-day activities of the BI production lab including resource planning, Daily Management, ensuring smooth workflow and adherence to production schedules and meeting KPI targets

+ Develop, improve, and implement standard operating procedures (SOPs) for spore culture production and related activities.

+ Mentor and train laboratory Scientists and Biotechnicians, providing guidance and support in their daily tasks.

+ Lead process changes for Biological Indicator production such as manufacturing steps, process, or equipment validations, product testing, ensuring robust processes that meet CTQs

+ Monitor and maintain laboratory equipment to ensure optimal performance and compliance with safety and regulatory standards.

+ Work closely with manufacturing engineers to integrate biological indicator manufacturing equipment, processes, and systems

+ Manage laboratory studies, projects, and processes/initiatives as well as initiates and completes technical reports

+ Lead and document technical investigations, NCs, or CAPAs associated with biological indicator or other consumable processes, systems, or products according to GMP principals and procedures

+ Demonstrate proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and lead process and business improvement activities

+ Be responsible for communicating business related issues or opportunities to next management level

+ Performs other duties assigned as needed

+ Prepare and assist of strategic vision or plan by collaborating with other cross functional departments

+ Represent production lab in Kaizens, workshops, PSP, and other problem solving and improvement projects

+ Meet and ensure adherence to compliance standards including monitoring, compliance with the relevant guidance documents, such as from ISO and FDA, and in preparation of documentation demonstrating compliance

Qualifications

Education

Minimum experience and education for this position is a bachelor’s degree in a scientific discipline, such as Microbiology, Biochemistry, Biomedical Engineering or a closely related field with 5 – 7 years of applicable experience, or a master’s degree with 3 – 5 years of applicable experience, or a PhD degree with 0 – 2 years of applicable experience

**Years of Related Experience** :

+ At least 4 years of experience in the Medical Device or other GxP-regulated industry preferred

+ At least 2 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferred

+ Additional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements preferred

+ Professional experience and understanding of QSR, FDA, and ISO guidelines preferred

**Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations** :

+ Proven experience in leading and managing laboratory activities, teams, and projects

+ Hands-on experience supporting bacterial endospore production, biological indicator manufacturing and terminal sterilization, and a thorough understanding of microbiology sterilization principles is preferred

+ Experience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied is preferred

+ Capability to develop study protocols, analyze data, and propose theoretical solutions/explanations for sterilization or biological indicator manufacturing studies (e.g. stability testing). Sounds statistical analysis is required (i.e., Minitab, etc.)

+ Capability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, quality engineering, etc.)

+ Knowledge AAMI/ISO standards in the area of biological indicators and/or terminal sterilization

+ Demonstrated experience in process development and/or validation preferred

+ Knowledge of analytical techniques and experience with analytical method development, validation, and transfer preferred

+ Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred

+ The successful candidate must be self-driven, innovative, have strong critical thinking and problem-solving skills, and capable of working independently or in a team

+ Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment

Responsibility for Others and Internal Interactions

+ This person may supervise or train junior scientists and lab technicians

+ Collaborate with Quality Assurance, Supply Chain, and Regulatory Affairs partner

Fortive Corporation Overview

Fortive’s essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to advanced technologies that help providers focus on exceptional patient care.

We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About Advanced Sterilization Products

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at [email protected].

Bonus or Equity

This position is also eligible for bonus as part of the total compensation package.

Pay Range

The pay range for this position (in local currency) is 44.06 - 81.77 hourly

This position is also eligible for bonus as part of the total compensation package.

The pay range for this position (in local currency) is 44.06 - 81.77 hourly

We are an Equal Opportunity Employer

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at [email protected].