Sterility Assurance Scientist

Medasource; Charlotte (NC); Vor Ort; USD 76.000 - 90.000; Teilzeit

Zusammenfassung

Medasource is seeking an experienced Sterility Assurance Scientist to support parenteral manufacturing operations on the Charlotte, NC shop floor. This role requires strong aseptic processing, sterility assurance, environmental monitoring, and contamination control expertise.

The position offers 12-hour night shifts on a rotating 2-2-3 schedule, with initial training conducted on day shift. You will collaborate with Manufacturing, Quality Assurance, EM, and technical teams to maintain cGMP

Qualifikationen

• Bachelor's degree in a life-science or related field.
• Experience in a cGMP pharmaceutical environment.
• Hands-on troubleshooting on manufacturing floor.
• Experience with deviation investigations and CAPA development.
• Ability to train and mentor manufacturing staff.
• Able to work 12-hour night shifts on a rotating schedule.

Aufgaben

• Provide hands-on technical support to manufacturing personnel during aseptic production activities.
• Monitor aseptic practices and reinforce cleanroom procedures.
• Troubleshoot process issues and respond to events requiring aseptic interventions.
• Support remediation activities, including recovery cleaning and CAPA implementation.
• Coach operators on aseptic techniques, gowning, and contamination control.
• Collaborate with QA, Operations, and technical teams to ensure sterility and product quality.
• Lead deviation investigations and root cause analysis, and develop CAPAs.
• Analyze manufacturing, microbiology, and EM data to identify trends and opportunities for improvement.
• Support qualification, validation, and contamination control strategy implementation.

Kenntnisse

Aseptic processing

Environmental monitoring

Sterility assurance

cGMP

Root cause analysis

CAPA

Manufacturing floor experience

Training/mentoring

Ausbildung

Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Tools

Veeva Vault Quality

TrackWise

Kneat

PharmaSuite

PI Vision

Jobbeschreibung

Sterility Assurance Scientist – Night Shift

Location: Charlotte, NC Area

Pay Rate: $55–$65/hour

Employment Type: 12-Month Contract

Schedule: 12-Hour Night Shifts | Rotating 2-2-3 Schedule

Training: Initial training conducted on day shift

Position Overview

We are seeking experienced Sterility Assurance Scientists to support our client's parenteral pharmaceutical manufacturing operations in the Charlotte, NC area.

This is a hands-on, manufacturing-floor-focused opportunity for professionals with a strong background in aseptic processing, sterility assurance, environmental monitoring, and contamination control.

The Sterility Assurance Scientist will provide technical guidance during manufacturing operations, troubleshoot aseptic processing challenges, support deviation investigations, and assist in implementing sterility assurance programs. This individual will work closely with Manufacturing, Quality Assurance, Environmental Monitoring, and technical teams to ensure compliance with cGMP standards and maintain product quality.

The ideal candidate is comfortable working directly on the manufacturing floor, coaching operators, identifying potential contamination risks, and responding to real-time production challenges.

Key Responsibilities

Manufacturing Floor & Aseptic Process Support

• Provide hands-on technical support to manufacturing personnel during aseptic production activities.
• Monitor aseptic practices, identify contamination risks, and reinforce proper cleanroom procedures.
• Troubleshoot manufacturing process issues and respond to unplanned events requiring aseptic interventions.
• Support remediation activities, including recovery cleaning, alarm responses, and manufacturing disruptions.
• Coach and mentor operators on aseptic techniques, gowning requirements, and contamination control practices.
• Collaborate with manufacturing supervisors and technical teams to address sterility and product quality concerns.

Deviation Investigations & CAPA

• Lead and support deviation investigations related to sterility assurance and manufacturing-floor events.
• Perform root cause analysis and develop corrective and preventive actions (CAPAs).
• Partner with Quality Assurance, Operations, and technical teams to evaluate potential impacts on product quality.
• Analyze manufacturing, microbiological, and environmental monitoring data to identify trends and opportunities for improvement.
• Support CAPA implementation, effectiveness monitoring, and continuous improvement initiatives.

Sterility Assurance & Technical Programs

• Provide technical support for sterility assurance programs, including:
• Environmental Monitoring (EM) and performance qualifications
• Aseptic Process Simulations (APS/media fills)
• Airflow pattern testing (smoke studies)
• Bioburden qualification and contamination control
• Cleaning, sanitization, and disinfection programs
• GMP gowning and aseptic processing techniques
• Isolator glove management and integrity testing
• Assist with qualification and validation activities, including performance validation protocols and manufacturing process studies.
• Support environmental monitoring investigations, data evaluation, and trend reporting.
• Contribute to the development and implementation of contamination control strategies.

Cross-Functional Collaboration

• Work closely with Manufacturing, Quality Assurance, Environmental Monitoring, Engineering, Maintenance, and technical teams.
• Serve as a technical resource for sterility assurance, aseptic operations, and contamination control.
• Support training and knowledge transfer for manufacturing operators, scientists, and technicians.
• Communicate technical observations, investigation findings, and recommendations to site leadership.

Required Qualifications

• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific or technical field.
• Experience supporting pharmaceutical or biopharmaceutical manufacturing operations within a cGMP-regulated environment.
• Strong understanding of aseptic processing, microbiology, environmental monitoring, sterility assurance, validation, and/or quality assurance.
• Hands-on experience troubleshooting manufacturing processes and supporting production activities.
• Experience with deviation investigations, root cause analysis, and CAPA development or execution.
• Ability to collaborate with Manufacturing, Quality, and technical teams.
• Experience providing technical guidance, training, or mentorship to manufacturing personnel or technical staff.
• Ability to work on the manufacturing floor and wear required cleanroom gowning and PPE.
• Willingness and ability to work 12-hour night shifts on a rotating 2-2-3 schedule.

Preferred Qualifications

• 5+ years of relevant pharmaceutical or biopharmaceutical manufacturing experience.
• Background in Sterility Assurance, MSAT/MS&T, Technical Services/Manufacturing Sciences (TS/MS), Environmental Monitoring, Parenteral Operations, or Process Engineering.
• Experience supporting aseptic filling, formulation, or visual inspection operations.
• Experience working in commercial pharmaceutical manufacturing or 24/7 production environments.
• Familiarity with GMP documentation, deviation management, and change control systems such as Veeva Vault Quality, TrackWise, or Kneat.
• Experience with data analysis and trending tools such as PharmaSuite, MODA, PI Vision, or Citrix Global Reports Generator.
• Strong communication, problem-solving, and technical troubleshooting skills.
• Night Shift: 12-hour shifts on a rotating 2-2-3 schedule.
• Rotation: Three shifts one week and four shifts the following week.
• Training: Initial training will take place on day shift before transitioning to nights.
• Work Environment: Primarily onsite within pharmaceutical manufacturing and cleanroom environments.
• Flexibility may be required to support production schedules, shutdowns, and operational needs.
• Position requires prolonged periods of standing or walking and adherence to all site safety and gowning requirements.