Full-Time
Validation Engineer 2/3
Csv
Posted on 7/14/2025
Genezen
201-500 employees
Viral-vector and cell-therapy CDMO provider
Compensation Overview
$85k - $130k/yr
No H1B Sponsorship
Lexington, MA, USA
In Person
 QA & Testing (2) |
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- A minimum of a Bachelor's degree in Engineering.
- Five or more years of validation experience.
- The individual must possess strong written and oral communication skills: The ability to communicate with employees of all experience levels.
- The ability to report on project activity in a clear and concise manner.
- The ability to negotiate when necessary and compromise with other project team representatives to achieve project goals.
- The ability to listen and respect fellow project team member’s ideas and opinions and work through conflict and disagreements.
- GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity Guidance, ICH Q7A requirements, and GAMP 5.
- Experience in thorough testing of applications, computerized systems, changes and implementations.
- Excellent written and oral communication to include accurate and legible documentation skills.
- Ability to work independently in a fast-paced environment with a strong work ethic.
- Must be able to sit or stand for prolonged periods of time.
- Good knowledge and skills in engineering of Automation for HVAC/ Process Utility/Monitoring Building Management Systems.
- Fully onsite position
- Adaptability required as work schedule may change based on business needs.
- Criminal background check required.
- Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
- Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
- Investigates / troubleshoots validation problems.
- Support and/or initiate investigations into protocol non-conformances and site deviations.
- Serve as initiator and owner of validation related change controls and corrective and preventative actions.
- Provides input to standard operating procedures related to validation practices.
- Support the implementation of validation programs (e.g., requalification).
- Represent the validation department at team meetings or projects.
- Performs periodic reviews and ongoing support of validated systems post Go-Live.
- Perform revalidation and change control validation related activities.
- Ability to apply complex system validation principles to work assignments.
- Responsible for executing and reviewing control systems validation activities including projects associated with Building Management Systems, Computerized Management Systems, and other automation upgrades.
- Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
- Assist validation activities of cross functional teams that include technical functions such as Quality Control, Information Systems, Manufacturing and QA Engineering.
Genezen is a contract development and manufacturing organization specializing in gene and cell therapies, focusing on viral vectors, transduced cells, and related analytics. It offers end-to-end, fee-for-service development and cGMP manufacturing from early development to clinical-grade vectors for trials. It differentiates itself by providing a focused, global CDMO service that covers the full pipeline for viral vectors and cell therapies under one partner. Its goal is to help clients advance gene and cell therapy programs toward clinical trials and potential treatments through reliable development, manufacturing, and testing support.
Company Size
201-500
Company Stage
Growth Equity (Venture Capital)
Total Funding
$18.5M
Headquarters
Iowa City, Iowa
Founded
2014
Simplify's Take
What believers are saying
- Rising demand for oncolytic viruses boosts partnerships like Optieum for glioblastoma.
- Board additions of Dr. Stetkiewicz and Auerbach on November 7, 2024 enhance strategy.
- Mike Wourms' COO appointment optimizes expanded manufacturing operations.
What critics are saying
- Sala BioPharma's 164,000 sq ft facility erodes Genezen's Boston market share.
- FDA Form 483 citations at Lexington halt AAV production within 3-6 months.
- Lonza's $1.4B CCRM acquisition poaches Genezen's lentiviral clients by 2027.
What makes Genezen unique
- Genezen specializes in viral vector CDMO for gene and cell therapies.
- Acquired uniQure's Lexington facility in July 2024 for commercial AAV.
- Partners with Humane Genomics on HGI627 oncolytic therapy since November 2025.
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Benefits
Paid Vacation
Paid Sick Leave
Paid Holidays
401(k) Company Match
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Growth & Insights and Company News
6 month growth
↑ 1%1 year growth
↑ 1%2 year growth
↑ 1%Genezen announces manufacturing partnership with Humane Genomics to advance oncolytic virus therapy for pediatric liver cancer. INDIANAPOLIS and NEW YORK, Nov. 12, 2025 /PRNewswire/ - Genezen, a leading viral vector Contract Development and Manufacturing Organization (CDMO), and Humane Genomics, a biotechnology company developing oncolytic viral therapies, today announced a partnership for process transfer and cGMP manufacturing of HGI627, a novel therapy targeting pediatric liver cancer (hepatoblastoma). Humane Genomics uses its proprietary synthetic RNA virus platform to rapidly design and engineer RNA viruses with precise anti-cancer capabilities. Through a two-factor selectivity mechanism, these therapies infect and replicate only in targeted cancer cells, leaving healthy tissue unharmed. The company's platform powers a growing pipeline of next-generation viral therapies across multiple cancer types, including their lead candidate, HGI627. Under this collaboration, Genezen will perform technology transfer, process development, and cGMP manufacturing of the VSV-based HGI627 therapy. "Genezen is excited to partner with Humane Genomics on this novel cancer treatment and provide our best-in-class manufacturing expertise to bring this critical therapy to life for pediatric patients," said Steve Favaloro, chairman and chief executive officer of Genezen. "This partnership reinforces our commitment to supporting innovators at every stage of development and highlights the deep technical expertise and commitment to patients of the Genezen team." Peter Weijmarshausen, co-founder and chief executive officer of Humane Genomics, added, "We are thrilled to partner with Genezen. Their experienced, dynamic team and state-of-the-art facilities make them a perfect match to turn our groundbreaking science into real therapies for patients." About Genezen Genezen is a best-in-class gene therapy CDMO with over a decade of experience and state-of-the-art viral vector manufacturing facilities. From concept to commercial scale, Genezen partners with innovators to deliver life-saving gene and cell therapies worldwide. Learn more at genezen.com or follow Genezen on LinkedIn. About Humane Genomics Humane Genomics develops oncolytic viral therapies using a groundbreaking RNA virus platform designed to selectively target cancer cells. Learn more at humanegenomics.com or follow Humane Genomics on LinkedIn. View original content to download multimedia:https://www.prnewswire.com/news-releases/genezen-announces-manufacturing-partnership-with-humane-genomics-to-advance-oncolytic-virus-therapy-for-pediatric-liver-cancer-302612525.html
Genezen partners with Charlotte & Gwenyth Gray Foundation on CLN6 Batten Disease. Imagine a disease that robs you of your sight, your movement, and cognitively impairs you before it becomes fatal? Now imagine this happening to a child. This is often the reality of Batten's disease. The team at Genezen is honored to partner with the Charlotte & Gwenyth Gray Foundation, started by two parents committed to finding a cure for Batten Disease to save the lives of their daughters; the Foundation recognizes firsthand the day-to-day challenges of living with a rare disease. In addition to funding research, the Foundation also provides financial support to families for education, patient therapies, and equipment critical to their well-being and rehabilitation. While Genezen Inc. can't disclose the current project Genezen Inc. is working on together, Genezen Inc. look forward to sharing its progress in 2026. To learn more about Batten Disease and the work the foundation is doing, visit https://www.curebatten.org/education/
Genezen named a BioSpace 2026 Best Places to Work winner. Genezen Inc. is thrilled to announce that Genezen Inc. has been named a BioSpace 2026 Best Place to Work. As a best-in-class gene therapy CDMO, Genezen Inc. pride ourselves on its flexibility and scalability of its sites to work with innovators at every stage to deliver life-saving gene and cell therapies worldwide. With over a decade of experience and state-of-the-art viral vector manufacturing facilities, Genezen Inc. tailor its partnership-model approach to all sizes and stages of organizations, to make viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. But what truly sets Genezen Inc. apart is its world-class team. As problem solvers who appreciate other problem solvers, its existence and operations always point forward to scientific advancement as Genezen Inc. seek to connect good science with better cures. Skill and progress are developed through dedication and hard work. Genezen Inc. succeed in teams who are flexible and collaborative. Genezen Inc. is all solution architects - thriving in a rapidly changing environment - leveraging the power of viral vectors to contribute to the advancement of cutting-edge therapeutics. Partnership is its priority. Genezen Inc. tap into its superior service and technical expertise to help its clients create gene and cell therapy products of the highest quality. To achieve this, Genezen Inc. seek team members who not only have the technical expertise required, but also offer proactive, collaborative, and creative solutions to drive customer success. Together, Genezen Inc. is bringing therapies to life. And its recognition as a BioSpace 2026 Best Places to Work winner demonstrates that its people are proud of the work Genezen Inc. do together. BioSpace, the leading source for life sciences news and careers, includes 50 U.S. operating employers in its Best Places to Work list that have been recognized as the most sought-after in the industry by the life sciences community. Genezen is honored to have been included in the small employer category. "This award is incredibly meaningful to us, especially as it symbolizes how we truly live our patient-focused CURES values here at Genezen," said Steve Favaloro, Chairman and CEO. "The recognition also illustrates our positive reputation in the field and the value that we provide to our business partners. I am proud to be a part of this organization and to work alongside individuals who are passionate about making a difference continue to pursue innovation in this field. It's not easy work, but it's always fulfilling." This is BioSpace's fifth Best Places to Work list. The list demonstrates a company's desirability in the recruitment marketplace, based on the votes and ratings of thousands of life science community members. BioSpace considers each organization's merits with particular emphasis on culture, career growth and development opportunities, leadership and innovation. Genezen Inc. is proud of the culture Genezen Inc. has built together. Its CURES values - a commitment to science, acting with urgency for patients, and executing with excellence and integrity - ground Genezen Inc. and empower Genezen Inc. to grow stronger together. If you're someone who wants to promote scientific advancement while growing personally and professionally, you may be a perfect fit for Genezen. Browse its current openings here: https://www.genezen.com/careers/join-the-team/#jobopenings Its BioSpace Best Places to Work achievement is underscored by its recent Massachusetts Life Sciences Center (MLSC) award. Massachusetts Governor Maura Healey and the MLSC have announced more than $17 million in tax incentives to help create 800 new jobs across the state's thriving life sciences industry. Genezen Inc. is proud to share that Genezen was among the companies selected to receive an award. This grant will help Genezen Inc. continue investing in growth, innovation, and job creation in the life sciences space - driving forward its mission to advance cell and gene therapies through science-driven development and manufacturing solutions and make a lasting impact on patients. About Best Places to Work Nominations for Best Places to Work were open in June 2025. Voting was conducted in August 2025. BioSpace reviewed the votes and rankings submitted by over 7,500 life sciences professionals. Respondents were asked to identify their top three most desirable biopharma companies, segmented by large (more than 1,000+ employees) and small (less than 1,000 employees) organizations. Respondents were also asked to rate their top choice organization on attributes including compensation, innovation, career growth opportunities, leadership, culture, diversity, equity and inclusion, reputation, and flexibility and remote work. About BioSpace BioSpace is the hub for life science news and jobs. Genezen Inc. provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe. Learn more and subscribe at www.biospace.com
Optieum Biotechnologies and Genezen are teaming up to help develop OPTF01, an experimental cell therapy for glioblastoma, an aggressive form of glioma.
Genezen, a specialist in viral vector development and manufacturing, has partnered with Optieum Biotechnologies, a preclinical-stage company focused on CAR-T cell therapies, to support the cGMP manufacturing of a lentiviral vector (LVV) construct for a new CAR-T therapy known as OPTF01.