The Staffing Resource Group, Inc
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Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
Key responsibilities:
Validation Engineer
Posted: 08/21/2024
2024-08-21
2024-10-14
Employment Type:
Contract
Division: Life Sciences
Job Number: JN -082024-19476
State: Texas
Job Description
Validation Engineer
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Validation Engineer
- Location: Houston, TX
- Industry: Pharmaceutical
- Hours: M-F: 8-5
- Salary: up to $68.94/ hr Paid Weekly (Benefits are Available) (some pay flexibility possible)
- Employment Type: 6 month Contract
Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
Key responsibilities:
- Develop, execute, and review comprehensive validation protocols for autoclaves and sterilizers, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Conduct thorough risk assessments to identify potential equipment and process-related risks and implement effective mitigation strategies.
- Collaborate with cross-functional teams, including engineering, production, and quality assurance, to ensure seamless validation execution and compliance.
- Author and maintain detailed validation documentation, including protocols, reports, and deviations.
- Investigate and resolve validation-related deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs) as needed.
- Stay up-to-date with industry regulations and standards (e.g., FDA, EMA, GMP, ISO) to ensure compliance.
- Provide technical expertise and support for autoclave/sterilizer-related inquiries and investigations.
- Participate in continuous improvement initiatives to enhance validation processes and efficiency.
Key requirements:
- Bachelor's degree in Engineering, Science, or a related field.
- Minimum of 5 years of experience in autoclave/sterilizer validation within the pharmaceutical or medical device industry.
- In-depth knowledge (SME Level) of autoclave/sterilizer principles, operation, and maintenance.
- Experience with Control Systems (PLC, HMI, SCADA).
- Experience in Computer System Validation.
- Experienced in Qualifying Purified water system, and Pure Steam Generators.
- Experience using Temperature Dataloggers like Kaye AVS, Ellab EValPro.
- Strong understanding of validation methodologies and regulatory requirements (FDA, EMA, GMP, ISO).
IND123
EOE/ADA
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Discover exciting job opportunities in the vibrant region around Houston, Texas! Known for its thriving economy, diverse industries, and endless growth prospects, Houston offers an enticing landscape for career-minded individuals. With world-class museums like the Museum of Fine Arts and a rich culinary scene showcasing Tex-Mex delights, BBQ joints, and food trucks serving up local flavors, Houston is a melting pot of culture and creativity. Home to the renowned Space Center Houston, the historic Astrodome, and professional sports teams like the Rockets and the Astros, this region exudes energy and excitement. Embrace the charm of this dynamic area while exploring job listings that could lead you to a fulfilling career right here in Houston!
For more than 30 years, SRG4 has worked with clients in Fortune 100 corporations, as well as emerging and rapid growth companies, located throughout the United States and globally.
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