Senior Scientist, Quality Control - Equipment

Role Summary

Senior Scientist, Quality Control – Equipment. Responsible for asset delivery and maintenance in the Quality Control Laboratory, ensuring compliance with quality systems and lab methods for analytical/microbiology equipment.

Responsibilities

• Maintains a safe work environment, leads safety initiatives, and supports Health, Safety, and Environmental goals.
• Authors equipment qualification/validation protocols and strategies for the QC Laboratories.
• Provides support for equipment relocation and qualification related to Lab master plans.
• Participates in data integrity by design and improvement initiatives.
• Executes technical review and execution of qualification/validation protocols.
• Recommends and specifies equipment purchases based on user requirements.
• Communicates with other functions and external vendors regarding qualification issues and key objectives.
• Acts as liaison between maintenance and laboratory personnel to schedule preventive and corrective maintenance.
• Applies knowledge of quality principles, cGMPs, and regulatory standards in equipment lifecycle management.
• Interacts with support groups and vendors; shares best practices to meet customer needs.
• Identifies improvements and streamlines quality systems relating to equipment.
• Serves as equipment subject matter expert in technical document reviews; origins changes controls.
• Origins and investigates deviations in the QC laboratory.
• Multitasks, prioritizes, and coordinates work to meet laboratory needs; demonstrates problem solving.
• Works independently with minimal supervision; performs routine maintenance and repairs.

Qualifications

• Required: Bachelor's degree in science, engineering, or pharmaceutical-related field or equivalent experience.
• Required: Minimum 5 years in the pharmaceutical industry with QC and laboratory equipment experience.
• On-site presence required.

Skills

• Fluent in English; strong written and oral communication.
• Understanding of cGMP regulations and regulatory expectations for laboratory systems.
• Experience supporting laboratory equipment in GMP environments, including repair/maintenance.
• Ability to manage multiple projects, adapt to changing priorities, and drive continuous improvement (LEAN).
• Proficiency with CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva; MS Office; laboratory systems.
• Strong analytical, problem-solving, and decision-making abilities; technical writing skills.
• Ability to train and mentor others; project management experience.
• Root cause analysis/troubleshooting; attention to detail; effective teamwork and communication.

Education

• Bachelor's degree in a science, engineering, or pharmaceutical-related field or equivalent experience.

Additional Requirements

• Primary work location: Kenosha County, Wisconsin.
• Travel: approximately 10% travel requirement.
• Overtime as required.