Microscopy Lab Technician

Job Description

Job Description

Full Description

Responsibilities :

The successful candidate will play a key role in ensuring microbiological control systems are qualified and validated, and that all microbiological testing methods meet regulatory standards.

Environmental Monitoring :

Lead and manage environmental monitoring (EM) programs in controlled environments (e.g., clean rooms, manufacturing facilities).

Oversee microbial testing, environmental sampling, and the qualification of monitoring systems.

Process Qualification & Validation :

Develop, implement, and execute qualification protocols for environmental monitoring systems, ensuring they meet GMP and regulatory requirements.

Lead the qualification and validation of microbiological testing methods, including methods for bioburden, endotoxin, sterility, and microbial limits testing.

Data Analysis & Reporting :

Analyze microbiological data from environmental monitoring, identifying trends, issues, and opportunities for continuous improvement.

Prepare and present comprehensive reports to key stakeholders.

Regulatory Compliance :

Ensure compliance with FDA, EMA, GMP, and other regulatory guidelines related to environmental monitoring and microbiological testing.

Maintain up-to-date knowledge of applicable standards.

Validation & Qualification Protocols :

Develop, validate, and implement environmental qualification and monitoring plans, ensuring that environmental control systems function as intended.

Qualifications :

Bachelor's degree (or higher) in Microbiology, Biology, Environmental Science, or a related field.

Minimum of 3 years of experience in microbiology, with a focus on environmental monitoring, qualification processes, or related fields in a regulated environment (pharmaceutical, biotechnology, medical devices, etc.).

Expertise in Environmental Monitoring :

In-depth knowledge of environmental monitoring best practices, qualification protocols, microbial testing techniques, and associated instrumentation.

Process Qualification : Strong understanding of process qualification procedures, including IQ / OQ / PQ (Installation Qualification, Operational Qualification, Performance Qualification) protocols.

Regulatory Knowledge : Familiarity with global regulatory requirements and standards (e.g., FDA, EMA, ICH, GMP) pertaining to environmental monitoring and microbiological control.

Strong skills in Environmental Monitoring, Process Qualification, and Method Validation.

Requires a blend of technical expertise, regulatory knowledge, and a strong ability to document and execute different microbiological processes.

Benefits :

Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.