Careers

Description:

The Environmental Monitoring Technician will plan, organize, and execute protocols with minimal supervision following GLP and cGMP guidelines, performing routine tasks independently and maintaining accurate documentation. Present results to team members, assist in preparing quarterly EM trending reports, and support raw material testing as needed. Stay current with scientific literature to contribute to group goals, prioritize tasks to meet deadlines, and assist with additional tasks as required.

What You Need to Succeed

• Plan, organize, and execute protocols under minimal supervision following GLP and cGMP guidelines.
• Work independently to perform routine tasks according to current written protocols.
• Maintain accurate and detailed documentation according to regulatory guidelines.
• Periodically present results and summarize progress to team members.
• Assist in preparation of quarterly EM trending reports
• Assist in performing raw material testing as necessary per written protocols.
• Intellectually contribute to group goals by staying current with scientific literature and state-of-the-art methodology.
• Effectively prioritize tasks to meet goals and drive projects to completion according to timelines.
• Flexibility to assist in other tasks as required.
• Ability to follow Gowning Procedure to don aseptic gowning for entry into classified areas.
• Ability to follow Environmental Monitoring procedure to collect a variety of samples inside the classified areas.
• Ability to complete documentation following Good Documentation Practices guidelines to capture data from sample collection activities.
• Maintain good communication within the Micro team and across different areas including Quality, Manufacturing and Facilities.
• Adhere to Aseptic techniques outlined in IVT-MFG-940 to maintain sterility of product and the environment.
• Adherence to Good Manufacturing Processes as defined by various regulatory guidance.

Skills/Eligibility:

Required Qualifications:

• Good aseptic technique and proficiency handling microbial cultures.
• Experienced or knowledgeable in working in a regulated cGMP environment.
• Familiarity with Environmental Monitoring principles
• Excellent verbal and written communication skills.
• Proficiency in computer systems and Microsoft Office suite.
• Ability to perform data analysis, trending and generate reports as required.
• Ability to strive in a fast-paced, creative, and goal-oriented environment.
• The candidate shall have at a minimum a bachelor’s degree in microbiology or other scientific discipline.
• Work experience in the field must be at least 2+ years.