
Controlled Environment Specialist
Welcome to PPD-Pharmaceutical Product Development, a global contract research organization dedicated to helping our clients bring life-changing therapies to patients faster. We are currently seeking a highly skilled and experienced Controlled Environment Specialist to join our dynamic team. In this role, you will play a critical role in ensuring the integrity and safety of our controlled environments, which are essential to the development and manufacturing of pharmaceutical products. If you have a strong background in environmental monitoring, proficiency in regulatory guidelines, and a passion for maintaining high quality standards, we would love to hear from you. Come join us and be a part of our mission to improve lives.
- Conduct routine environmental monitoring and testing in controlled environments to ensure compliance with regulatory guidelines and company standards.
- Develop and implement standard operating procedures for maintaining controlled environments.
- Perform data analysis and interpretation of environmental monitoring results.
- Identify and troubleshoot any issues with controlled environments and take necessary corrective actions.
- Collaborate with cross-functional teams to ensure controlled environments are properly maintained and any issues are addressed in a timely manner.
- Stay up-to-date with industry trends and regulatory requirements related to controlled environments.
- Train and mentor staff on proper procedures for maintaining controlled environments.
- Participate in audits and inspections, providing necessary documentation and addressing any findings.
- Communicate effectively with clients and internal stakeholders to provide updates on controlled environment status and any relevant issues.
- Maintain accurate records and documentation related to controlled environments.
- Continuously evaluate and improve processes to enhance the quality and efficiency of controlled environment operations.
- Adhere to all safety protocols and procedures while working in controlled environments.
- Act as a subject matter expert on controlled environments and provide guidance to colleagues as needed.
- Collaborate with procurement to ensure necessary equipment and supplies are available for maintaining controlled environments.
- Represent the company in a professional and ethical manner at all times.
Bachelor's Degree In Microbiology, Environmental Science, Or A Related Field.
Minimum Of 2 Years Of Experience In A Controlled Environment, Preferably In A Pharmaceutical Or Biotech Setting.
Knowledge Of Relevant Regulations And Guidelines, Such As Fda And Cgmp Requirements.
Strong Understanding Of Aseptic Techniques And Cleanroom Operations.
Experience With Environmental Monitoring, Data Analysis, And Reporting.
Troubleshooting
Data Analysis
Quality Control
equipment maintenance
Risk assessment
Environmental monitoring
Sterilization techniques
Documentation management
GMP compliance
aseptic techniques
Regulatory
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
Organization
flexibility
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Controlled Environment Specialist is $40,000 - $70,000 per year. However, this can vary depending on the specific industry, location, and experience level of the individual. Some Controlled Environment Specialists may earn a higher salary if they have advanced certifications or specialized skills in areas such as HVAC systems or environmental regulations.
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PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

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