Scientist, Quality Engineering

Position: Scientist (Sunday - Wednesday)
** Production & Laboratory Operations*
* -Culture and test bacterial spores used in the biological indicator manufacturing process in accordance with cGMPs and approved SOPs

-Execute advanced production activities including:

- Spore inoculation and propagation;

- Agar pour plate preparation and testing;

- Sampling, testing, and data generation

-Prepare, review, and verify batch records and production documentation in accordance with cGDP requirements

-Provide technical support for both new and existing products during routine manufacturing and scale‑up activities

** Troubleshooting, Investigations & Technical Support*
* -Investigate and troubleshoot product deviations, process excursions, and production issues using appropriate scientific and technical diagnostic methods

-Support problem investigations, inspections, and root cause analyses as directed

-Apply standard scientific principles, theories, and concepts to evaluate data, identify root causes, and recommend corrective actions

-Exercise judgment within established practices and procedures when selecting methods and techniques to resolve technical issues

** Process Development & Improvement*
* -Contribute to the origination, design, and execution of experiments, including:

- Development of methodologies;

- Review, analysis, and interpretation of data;

- Preparation of technical summaries and reports

-Support test method development, validation, and optimization activities

-Participate in process improvement initiatives, including Kaizen, 5S, and efficiency projects

** Systems & Area Ownership*
* -Own and manage assigned laboratory or operational systems, including:

- PMs and calibrations oversight;

- Inventory management and SAP transactions;

- Change Orders (COs), Nonconformances (NCs), Laboratory Investigations (LIs), and CAPAs

-Coordinate activities across cross‑functional teams including Quality, R&D, Production Planning, and Manufacturing Engineering

-Maintain clear and complete technical documentation for projects and assigned systems

** Training, Leadership & Communication*
* -Train, coach, and certify junior‑level employees on manufacturing procedures, test methods, and standard work

-Coordinate and manage independent projects under the guidance of process leaders and project facilitators

-Communicate technical risks, business issues, and improvement opportunities to management

-For individuals with supervisory responsibilities, ensure adherence to Health, Safety, and Environmental requirements

** Education and Experience Requirements*
* 2-4 years of relevant experience in a regulated laboratory or manufacturing environment; or

0-3 years of experience with a Master's degree; or

High School Diploma or equivalent with 8+ years of relevant industry experience.

Bachelor's Degree in Biology, Microbiology, or a related scientific discipline preferred

** Required Knowledge & Skills*
* -Strong knowledge of cGMP and cGDP requirements

-Experience working in an FDA‑regulated environment

-Laboratory experience in aseptic techniques and biologics manufacturing

-Ability to summarize, interpret, and report scientific data

-Proficiency with spreadsheet and database applications

-Effective written and verbal communication skills

-Ability to work collaboratively in cross‑functional teams

** Preferred qualifications*
* - Experience with SAP inventory or laboratory systems

- Experience with statistical tools (e.g., Minitab)

- Yellow Belt or Green Belt certification

- Train‑the‑Trainer or Training Within Industry (TWI) experience

** Work Environment &

Physical Requirements *
* - Schedule may include weekend work

- Domestic travel may be required (0-10%)

- Ability to lift 31-50 lbs

- Ability to wear required PPE

- Ability to work in a manufacturing laboratory environment

** 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…