About the job
Key Objectives/Responsibilities:
The Environmental Specialist is not only responsible for acting on behalf of the Environmental Supervisor by coordinating monitoring activities, but must sample as needed, review sampling for completeness and accuracy as needed, and identify any concern areas and trends in cleanroom. The Environmental Specialist must also complete investigation reports as well as conduct investigational environmental monitoring support of classified manufacturing, filling, and support areas for pharmaceutical operations.
A Environmental Specialist must also understand and provide training on current and upcoming regulatory standards pertaining to Environmental Monitoring and Quality Manufacturing. Update or create SOP’s to maintain cGMP compliance, implement best-practices for continuous improvement, and ensure data is processed in a way that accurately demonstrates our level of control.
Understand and provide training for the Environmental Control Monitoring System and Alarm Management System (be the company’s SME). Work with software vender, facility maintenance, outside contractors and coworkers to ensure the cleanroom is operating within a state of control. Interpret and report on facility data to other departments, customer audits and regulatory agencies. Maintain current understanding of what each facility’s normal operating state looks like.
Conduct risk assessments for routine operations, contamination events, and drifts from our normal operating state. Identify, investigate and report on any departmental concerns and trends. Conduct experiments to confirm our standards, inform our processes and establish states of control. Provide internal inspections to ensure regulatory compliance is maintained.
Respond to emergencies and develop a plan to contain contamination, gather data and prepare reports to be used in assessing impact.
Complete NOE’s and assist with Deviations and CAPA’s associated with EM and ECMS for the Quality Assurance Department. This includes reviewing security videos, interviewing personnel, conducting experiments, and obtaining continued education in the various systems/processes our facility employs.
Set yourself apart
You possess the following qualifications, background and abilities:
Basic Qualifications
- High School Diploma/GED
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
- Qualified candidates must be legally authorized to be employed in the United States.
Additional Skills/Preferences
- Strong understanding of cGMPs, regulatory standards/requirements for Environmental Monitoring.
- Strong documentation skills and attention to detail is required.
- Ability to work in a variety of manufacturing facilities/support environments
- Must be capable of working in a dynamic, fast-paced, and physically demanding environment with extended periods of standing/walking.
- Must be able to lift 30 pounds and be able to pass, push, and pull to execute aspects of job duty.
- Must be able to repeatedly gown in building dedicated uniform
- Strong computer skills in Microsoft Office products and Outlook.
- Environmental Monitoring experience preferred.
- Manufacturing or production experience preferred.
- Knowledge of / familiarity with parenteral production environments, operations
- Exceptional observational skills, ability to think analytically, and possess a great attention to detail
Additional Information
- EM Inspector position involves repetitive motions.
- Overtime may be required.
- Post offer testing exam may be required.
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.