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Validation Engineer
6 days ago
Alliance Biotech Solutions Raleigh, United StatesAlliance Biotech Solutions (ABS) is a quality partner providing first in class solutions to the biotech and life sciences industries. While our offers are limitless, we are focused on providing Engineering, Qualification, and Compliance solutions for our clients. ABS employees ar ...
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Validation Engineer
1 week ago
Surf Search Raleigh, United States Full timeThe Validation Engineer has a significant impact to the company. There is a high criticality level for the work produced. The Validation Engineer is responsible for all aspects of the validation process, including: documenting commissioning activities, establishing the process an ...
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Validation Engineer
3 weeks ago
Sequoia Biotech Consulting Raleigh, United StatesValidation Engineer · Position Overview: · We are looking for a talented and detail-oriented Validation Engineer to execute and oversee validation activities within our clients' pharmaceutical manufacturing facilities. The Validation Engineer will be responsible for planning, e ...
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Validation Engineer
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Valspec Raleigh, United StatesValidation Engineer (MES) · Location: Durham, North Carolina · Provide computer system validation support for a leading contract development and manufacturing organization (CDMO) specializing in the production of biologics and advanced therapies. We are seeking a flexible and a ...
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Validation Engineer
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Valspec Raleigh, United StatesJob Description · Job DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum ...
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Senior Validation Engineer
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Precision for Medicine Raleigh, United StatesSenior Validation Engineer · at Precision Medicine Group (View all jobs) · Raleigh, North Carolina, United States · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments We are thrilled to present an incredible opportunity to jo ...
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Validation Engineer
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Barry-Wehmiller Companies Inc Raleigh, United StatesAbout Us: · Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sector ...
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Cleaning Validation Engineer
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Mastech Digital Raleigh, United StatesRole: Cleaning Validation EngineerRaleigh, NCContract role. · Do you have the skills to fill this role Read the complete details below, and make your application today. · Job Description:Looking for a Cleaning Validation Engineer.Heavy background in Cleaning Validation in the b ...
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Validation Engineer/Process Engineer
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TOPSYSIT Raleigh, United StatesJob Title: Validation Engineer/Process Engineer · Client: Indivior · Location: 8900 Capitol Blvd, Raleigh, NC-27616 · Job Duties: · Review, develop and execute validation lifecycle documents like FAT, SAT and qualification protocols for new equipment and existing equipment enhanc ...
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Pharmaceutical - VALIDATION ENGINEER
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MMR Consulting Raleigh, United StatesJob Description · Job DescriptionSalary: · Pharmaceutical - VALIDATION ENGINEER · Previous Pharmaceutical/Biotech experience is mandatory for this role · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in the ...
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Validation Engineer
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BioAgilytix Durham, United StatesAt BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly ...
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GxP Validation Testing Engineer
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Cynet Systems Raleigh, United StatesJob Description: Strong Hands-On experience in GxP Validation Testing. · 12+ Yrs of experience is must. · Hands on experience in IQ, OQ, PQ protocol creation and review. · Good Knowledge on CFR Part11, Quality management system, Veeva or any DMS use. · Hands on expertise in ...
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Validation Engineer
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Renesas Morrisville, United StatesJob Description · Job Description Company Description · Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering product solutions i ...
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Process/Validation Engineer
1 week ago
Katalyst Healthcares and Life Sciences Durham, United StatesResponsibilities: Validation Planning: Develop and implement validation strategies, including process, equipment, and cleaning validation, in compliance with FDA and international regulatory guidelines. · Validation Protocol Design: Create and execute validation protocols (IQ, OQ ...
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Senior Software Validation Engineer
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Process Validation Engineer
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Katalyst HealthCares & Life Sciences Durham, United StatesResponsibilities: Develop and execute process validation protocols and reports in accordance with regulatory requirements and industry best practices. · Perform risk assessments and gap analyses to identify areas for process improvement and ensure the reliability of manufacturi ...
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Quality Validation Engineer
3 weeks ago
Accentuate Staffing Durham, United StatesAccentuate Staffing is partnering with a rapidly growing biotechnology company who is hiring for a Quality Engineer with a clearly demonstrated background in validation. This is a direct hire opportunity · Responsibilities: · Continuously evaluate and evolve Validation Policy an ...
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Validation Lead
4 days ago
LAPORTE Raleigh, United StatesThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with client's global/si ...
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Sr Manager, IT Quality Engineering
1 day ago
Gilead Sciences, Inc. Raleigh, United States Full timeDescription · Gilead's mission is to discover, develop and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a Sr Manager, IT Quality Engineering you are responsible for working closely with business leads and other IT partne ...
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Power Electronics Hardware Engineer
6 days ago
Advanced Technology Search Raleigh, United StatesOur client is a leading maker of high power plasma power supplies for industrial and government applications. Their power supplies are used for surface etching, air filtration, food processing, and semiconductor fabrication. They are currently seeking a Hardware Engineer responsi ...
Cleaning Validation Engineer - Raleigh, United States - HYDE ENGINEERING + CONSULTING
Description
The Cleaning Validation Engineer is responsible for cleaning and process engineering and validation in the biotech and pharmaceutical industries. This individual will generate, execute, and report on testing for multiple phases of commissioning and qualification.The position involves post cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility. Experience in CIP/COP and manual cleaning validation activities is required. Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred. Experience Developing documents and SOPs and prepare reports is required.
Must have experience analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures.
Generate and resolve protocol discrepancies or deviations. Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation. Train operations staff on protocols, procedures and technical details related to systems or processes. Organize, schedule and track validation projects in order to meet client requirements and agreed timelines.Hands-on experience with the following systems: CIP systems, SIP systems, cabinet washers, COP, manual cleaning is required.
Experience with sampling techniques.
Experience with development of manual cleaning protocols for Tablet press equipment is highly preferred.
Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position.
Experimental design and problem solving skills are preferred. Strong organizational skills and demonstrated ability to manage projects to completion are highly desired.
Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is preferred.
The Cleaning Validation Engineer is responsible for cleaning and process engineering and validation in the biotech and pharmaceutical industries. This individual will generate, execute, and report on testing for multiple phases of commissioning and qualification.
The position involves post cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility. Experience in CIP/COP and manual cleaning validation activities is required. Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred. Experience Developing documents and SOPs and prepare reports is required.
Must have experience analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures.
Generate and resolve protocol discrepancies or deviations. Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation. Train operations staff on protocols, procedures and technical details related to systems or processes. Organize, schedule and track validation projects in order to meet client requirements and agreed timelines.Hands-on experience with the following systems: CIP systems, SIP systems, cabinet washers, COP, manual cleaning is required.
Experience with sampling techniques.
Experience with development of manual cleaning protocols for Tablet press equipment is highly preferred.
Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position.
Experimental design and problem solving skills are preferred. Strong organizational skills and demonstrated ability to manage projects to completion are highly desired.
Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is preferred.
Qualifications:
Strong problem solving and decision making skills
Ability to understand and extract necessary information from technical documents
Ability to handle complex projects
Takes initiative to help drive projects forward and develop contingency plans when applicable
Ability to work on cross-functional project teams
Able to effectively manage workload and prioritize activities
Excellent verbal and written communication skills
Proven ability to review, interpret and make scientific conclusions and recommendations based on data
Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals
Effectively work within a team environment and interface with peers, management, etc.
Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint and Visio.
At Hyde Engineering + Consulting, we are an employee-owned firm comprised of industry experts looking to make a meaningful impact for our biopharmaceutical and pharmaceutical clients around the world.
We are uniquely positioned in the marketplace to provide solutions to support full-cycle project delivery starting with an optimized cleaning program developed by Hyde's ISO-90001 certified CORE Lab.
This work segues into state-of-the-art engineering, commissioning and qualification of facilities and equipment.As we continue to grow our operations around the world, we are hiring engineers and consultants who take ownership in their professional work as well as ownership in the long-term success of Hyde.
Our owners embody an entrepreneurial spirit, have diverse perspectives and a passion for learning while simultaneously cultivating lasting client relationships.
You will find these values reflected in our company:Family
Integrity
Friendship
Wisdom
Adventure
Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.
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