Scientist, Quality Engineering

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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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

The salary range for this position (in local currency) is 70,.

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. We are also committed to providing reasonable accommodations for applicants with disabilities.

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