BioSpace, Inc.
Job Details
Job Details Description Our rapidly growing analytical laboratory is a unique community of people and values. Our scientific and quality teams are looking to expand our community into the engineering world. The engineer will be involved in a variety of engineering tasks from equipment calibration, clean-room design and build to evaluating new processes for a large laboratory environment. What You Will Do
Apply the principles of science and mathematics to develop economical solutions to technical problems. Develop and write IQ, OQ and PQ protocols for laboratory equipment and execute them in compliance with GDP guidelines and internal quality standards. Manage environmental monitoring sensors and software for laboratory and lab equipment. Collect data, prepare reports, respond to issues promptly and implement corrective actions. Manage laboratory equipment records documentation related to maintenance, repairs, and performance. Procure parts, schedule work, document equipment performs metrics and downtime. Troubleshoot and investigate equipment and system issues. Interpret data, technical drawings, manuals, and schematics to correctly solve problems for laboratory and facility. Schedule and coordinate preventative maintenance and qualifications activities with vendors. Review, analyze and assemble results, draft validation reports. Assure that facilities operate in a safe and appropriate manner and comply with all federal, state, and local codes/regulations. Review mechanical/electrical portions of engineering designs prepared by Architect-Engineer firms for various systems and facilities including ISO certified cleanrooms and HVAC systems. Assist in conceptual design of cleanrooms, compounding rooms, and laboratory space. Work independently and manage projects for both internal and external customers. Be willing to travel to customer sites to perform and assist with calibration / qualifications activities including equipment and cleanroom certifications. Who You Are
B.S. in engineering (Electrical, Biomedical, Chemical, Mechanical, or Industrial preferred). A strong understanding of technical writing and presentation skills is required. CAD experience a plus. Electrical experience a plus. Experience with laboratory equipment a plus. Must be able to work independently, multi-task, and support multiple projects simultaneously. Ability to work in a team environment, communicate well both orally and in writing. Certifications:
•ASQE a plus Qualifications Skills
Behaviors : Motivations : Education Required Bachelors or better in Engineering or related field.
Experience Licenses & Certifications
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Company
Eagle, established in 2003, began as a dedicated partner addressing regulatory needs in the compounding industry. Over the years, it has evolved into a premier scientific solutions provider, with a distinguished FDA-registered CGMP testing/calibration laboratory spanning over 80,000 square feet. Equipped with state-of-the-art instrumentation, cutting-edge technologies, and advanced methodologies, Eagle delivers tailored, high-quality scientific solutions designed to meet the most rigorous industry standards.
Eagle is uniquely positioned to serve a diverse range of clients, including pharmaceutical drug and device manufacturers, 503B outsourcing facilities, 503A compounding pharmacies, hospitals, and clinical research organizations. We proudly serve clients throughout North America and globally.
Eagle's Mission
Our desire, dedication, and discipline to ensure that patient safety is at the forefront of everything we do and our holistic approach to resolving your compliance needs make Eagle a truly unique organization.
Our Vision
To guide and educate pharmacists and healthcare professionals to utilize fact-based decision-making to create science-based solutions. Research and develop innovative scientific approaches to solve healthcare challenges.
Company info Location 11111 S. Wilcrest Dr. Suite S1000 Houston TX 77099 United States
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Job Details Description Our rapidly growing analytical laboratory is a unique community of people and values. Our scientific and quality teams are looking to expand our community into the engineering world. The engineer will be involved in a variety of engineering tasks from equipment calibration, clean-room design and build to evaluating new processes for a large laboratory environment. What You Will Do
Apply the principles of science and mathematics to develop economical solutions to technical problems. Develop and write IQ, OQ and PQ protocols for laboratory equipment and execute them in compliance with GDP guidelines and internal quality standards. Manage environmental monitoring sensors and software for laboratory and lab equipment. Collect data, prepare reports, respond to issues promptly and implement corrective actions. Manage laboratory equipment records documentation related to maintenance, repairs, and performance. Procure parts, schedule work, document equipment performs metrics and downtime. Troubleshoot and investigate equipment and system issues. Interpret data, technical drawings, manuals, and schematics to correctly solve problems for laboratory and facility. Schedule and coordinate preventative maintenance and qualifications activities with vendors. Review, analyze and assemble results, draft validation reports. Assure that facilities operate in a safe and appropriate manner and comply with all federal, state, and local codes/regulations. Review mechanical/electrical portions of engineering designs prepared by Architect-Engineer firms for various systems and facilities including ISO certified cleanrooms and HVAC systems. Assist in conceptual design of cleanrooms, compounding rooms, and laboratory space. Work independently and manage projects for both internal and external customers. Be willing to travel to customer sites to perform and assist with calibration / qualifications activities including equipment and cleanroom certifications. Who You Are
B.S. in engineering (Electrical, Biomedical, Chemical, Mechanical, or Industrial preferred). A strong understanding of technical writing and presentation skills is required. CAD experience a plus. Electrical experience a plus. Experience with laboratory equipment a plus. Must be able to work independently, multi-task, and support multiple projects simultaneously. Ability to work in a team environment, communicate well both orally and in writing. Certifications:
•ASQE a plus Qualifications Skills
Behaviors : Motivations : Education Required Bachelors or better in Engineering or related field.
Experience Licenses & Certifications
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Company
Eagle, established in 2003, began as a dedicated partner addressing regulatory needs in the compounding industry. Over the years, it has evolved into a premier scientific solutions provider, with a distinguished FDA-registered CGMP testing/calibration laboratory spanning over 80,000 square feet. Equipped with state-of-the-art instrumentation, cutting-edge technologies, and advanced methodologies, Eagle delivers tailored, high-quality scientific solutions designed to meet the most rigorous industry standards.
Eagle is uniquely positioned to serve a diverse range of clients, including pharmaceutical drug and device manufacturers, 503B outsourcing facilities, 503A compounding pharmacies, hospitals, and clinical research organizations. We proudly serve clients throughout North America and globally.
Eagle's Mission
Our desire, dedication, and discipline to ensure that patient safety is at the forefront of everything we do and our holistic approach to resolving your compliance needs make Eagle a truly unique organization.
Our Vision
To guide and educate pharmacists and healthcare professionals to utilize fact-based decision-making to create science-based solutions. Research and develop innovative scientific approaches to solve healthcare challenges.
Company info Location 11111 S. Wilcrest Dr. Suite S1000 Houston TX 77099 United States
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