Job Description

About the Company

Lifecycle Biotechnologies, a TCP Analytical Company in the life science industry for 40 years is looking for an Environmental Monitoring Technician, based out of Cleburne, Texas.

About the Role

The Environmental Monitoring Technician is responsible for performing routine and investigational environmental monitoring activities in controlled and classified cleanroom environments, including aseptic processing areas. The role ensures all operations are compliant with cGMPs, Standard Operating Procedures (SOPs), and other regulatory requirements. This position is critical for maintaining product quality and ensuring a compliant manufacturing environment.

Responsibilities

• Aseptic sampling: Perform active viable air sampling, viable surface sampling (e.g., swabs, contact plates), and personnel monitoring according to established schedules and procedures.
• Non-viable particle counting: Conduct non-viable particulate monitoring in classified areas using specialized equipment to ensure particulate levels are within specified limits.
• Utility monitoring: Sample and test facility utility systems, including water (e.g., Water for Injection, Purified Water), compressed air, and gases for bioburden, total organic carbon (TOC), and conductivity.
• Sample incubation and analysis: Manage the incubation of collected samples and perform routine plate reading and microbial enumeration.
• Routine laboratory assays: Conduct routine laboratory assays as required.
• Documentation and data integrity: Accurately and legibly complete all required GMP documentation in real-time, including logbooks, datasheets, and laboratory notebooks, adhering to Good Documentation Practices (GDP).
• Reporting and investigations: Promptly report any out-of-specification (OOS), deviations, or excursion results to management. Assist in related investigations and root cause analysis.
• Equipment and inventory management: Ensure all monitoring equipment is calibrated and functions properly. Manage inventory of laboratory supplies and media.
• Continuous improvement: Participate in process streamlining and continuous improvement initiatives related to environmental monitoring.
• Compliance and safety: Adhere to all company safety, quality, and regulatory guidelines. Maintain a clean and orderly laboratory and cleanroom environment.

Qualifications

• High school diploma or equivalent is required.
• An Associate's or Bachelor's degree in a science-related field (e.g., Microbiology, Biology) is preferred.
• Experience with environmental monitoring or aseptic techniques in a regulated manufacturing environment (e.g., pharmaceutical, biopharmaceutical) is preferred.
• Strong understanding of cGMP regulations, FDA requirements (e.g., 21 CFR Parts 210 and 211, 820), ISO 13485, and aseptic techniques.
• Excellent attention to detail and strong organizational skills.
• Proven ability to complete documentation accurately and maintain data integrity.
• Strong verbal and written communication skills.
• Ability to work independently and as part of a team.
• Proficiency with basic computer applications, including Microsoft Office.

Equal Opportunity Statement

TCPA is proud to be an equal opportunity employer. We are an Equal Employment. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

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