Environmental Monitoring - Houston, TX | Biospace
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Environmental Monitoring

Bellicum Pharmaceuticals

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Location:
Houston, TX
Posted Date:
5/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Associates Degree
Areas of Expertise Desired:
Environmental Health & Safety,

Job Description


Bellicum Pharmaceuticals, located in the Houston Medical Center, is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders.  We are dedicated to creating an exceptional work environment where we develop products that can make a difference in the quality of life for patients.

Due to our continued growth, an excellent opportunity is available for an Environmental Monitoring Technician, reporting to the Contamination Control Supervisor.  As an Environmental Technician, you will have the chance to contribute to the pursuit, capture, management and execution of air and surface quality management and compliance.  The Environmental Technician is responsible for collecting and analyzing aseptic environment samples in support of GMP facility qualification. The individual selected for this position will be gowning into a ISO 5 facility. The technician will also be testing to support cleaning and product changeover in the facility.

Responsibilities:

•   Performs environmental monitoring in all manufacturing and support areas.
•   Performs personnel monitoring.
•   Performs data entry and review for analysis and trending.
•   Assists in analyzing data for the identification of trends.
•   Submits samples to contract test organization(s) for testing.
•   Assists in sample scheduling.
•   Keeps track of inventory and orders supplies as needed.
•   Performs basic maintenance, calibration and quality control of instruments used in EM.
•   Exercises aseptic techniques while collecting and analyzing EM samples.
•   Ensures that all activities are performed in compliance with approved validation/qualification protocols and SOPs to support company and validation policies as well as current regulatory requirements/guidelines.
•   Documents non-conformances and participates in investigations resulting from EM excursions, able to assist in root cause analysis.
•   Observes safety and security procedures.
•   Participates in validation of new laboratory equipment.
•   Maintains knowledge of regulatory standards, trends and compliance.

Requirements


•   Must have a minimum of an Associate Degree in biological sciences (microbiology) or related discipline preferably in Biotechnology or Biology.
•   Must have at least 2 years of related work experience in pharmaceuticals, biologics and quality control.
•   Must be familiar with environmental monitoring, cGMP and pharmaceutical and biopharmaceutical unit operations.
•   Proven understanding of environmental monitoring performance qualification of classified spaces, and willingness to learn skills required to author and execute IQ/OQ/PQ/PV documents, developing SOPs, final reports and author/adhere to the validation and quality policies/procedures/guidelines.
•   Must be familiar with clean rooms, cGMP and current industry guidelines and standards.
•   Sound knowledge of aseptic processing and supporting technologies.
•   Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication skills.
•   Must have excellent oral, written and interpersonal skills, are required.

We invite you to check us out www.bellicum.com. We offer a competitive Total Rewards program including stock options and employer supported benefit premiums. Interested candidates are invited to submit their resume.  We thank you for your interest in Bellicum and your submission. Please be advised that only those candidates selected to move forward will be contacted.