CQV Specialist
Katalyst HealthCares & Life Sciences
Job-ID32522601Reference26-01117Remote50% RemoteJob description: We are seeking a CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing. This individual will own qualification strategy and execution, ensuring compliant, risk-based validation aligned with USP <1058> , GAMP 5, and industry best practices. Responsibilities: Lead and own CQV activities across facility, QC, process, and computerized systems, including cleanrooms, smoke studies, and qualified equipment. Develop and execute robust, risk-based qualification strategies grounded in USP <1058> , GAMP 5, and system impact assessments (ISP guidelines). Author and execute validation plans, protocols, reports, risk assessments, and GxP documentation. Drive execution activities, proactively resolving issues, deviations, and remediation items during qualification. Lead deviation investigations, impact assessments, and corrective actions. Support qualification of cell therapy–specific and QC systems such as qPCR, BacT, Faxitron, and microplate readers. Quickly onboard to new projects and scopes, independently managing execution from planning through approval. Represent CQV activities during internal and regulatory inspections as needed. Requirements: 8+ years of CQV/validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing (cell therapy strongly preferred). Hands-on experience qualifying facility, equipment, and computerized systems. Strong working knowledge of USP <1058> , GAMP 5, and risk-based validation methodologies. Demonstrated experience owning validation programs, writing protocols, executing testing, and managing deviations. Ability to understand complex scope, define qualification impact, and implement compliant execution strategies. Excellent communication skills and ability to lead independently in fast paced GMP environments.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the CQV Specialist in Cambridge, MA vacancy
$89.59k - $197.46k
...excellence, delivers meaningful impact, and empowers you to shape your own future.KPMG is currently seeking a Senior Associate, Credit Specialist to join our Audit practice.Responsibilities:Execute the day-to-day activities of credit specialist component of audit engagements...SuggestedH1bLocal area$100k - $145k
...diverse client base, which includes governments, institutions, corporations and individuals worldwide.About the TeamThe Portfolio Specialist Team is a strategic function within Eaton Vance Equity, part of Morgan Stanley Investment Management. The team serves as the...SuggestedTemporary workWork at officeWorldwide$73.45k - $132.78k
Leidos is seeking an Airspace Specialist / Program Analyst to join the National Airspace System (NAS) Integration Support Contract (NISC IV) team.This is a telework position. Must be located in the Eastern part of the US. Primary Role & Receptibilities: Serve as an operational...SuggestedFull timeContract workWork at officeRemote work- The Private Banking Associate (PBA) serves as the primary sales support partner to Private Bankers and is responsible for the end-to-end onboarding and maintenance of private banking relationships. This role supports a seamless client experience across deposit and lending...SuggestedWork experience placementWork at officeWorldwideFlexible hours
$135k - $140k
...individuals with disabilities to perform the essential functions. Environmental exposure to infectious disease and radiation Clinical Specialists are required to be within their assigned territory each day to be available as unscheduled needs arise Clinical Specialists will...SuggestedFull timeWork experience placementH1bWork at officeLocal areaImmediate startRemote workWorldwideFlexible hoursNight shift$54k - $59k
...about making a difference in the lives of families? Thom Child & Family Services located in Boston, MA is seeking a Developmental Specialist/Early Childhood Educator to join their team. As an Early Intervention Early Childhood Educator or Developmental Specialist ,...Daily paidTemporary workWork experience placementWork from homeFlexible hours$94k - $117k
...is to reflect the diversity of our clients and the communities in which we practice.About the RoleThe Awards and Rankings Senior Specialist will focus on managing the end-to-end legal awards and directories opportunities for the firm and its lawyers. The Senior Specialist...$152.34k - $238.28k
What We're Looking ForAt HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the country...Full timeWork at officeLocal area- ...Beth Israel Deaconess Medical Center, Inc. is seeking a remote-call center scheduling specialist who directs patient access by answering and screening high volumes of calls from a dedicated queue. The role begins with onsite training and transitions to remote work, requiring...Remote work
$313.23k
...leadership position is responsible for the quality and execution of the Global Lightwell business and field execution for Lightwell specialists. This role is also responsible for developing and advocating Red Hat’s go-to-market (GTM) strategies and tactics for Lightwell...Permanent employmentFull timeContract workWork experience placementWork at officeRemote workFlexible hours$88k
...The Senior Strength and Conditioning Specialist serves as the lead representative for all matters related to strength and conditioning and injury mitigation for the Command. This role designs, administers, and refines evidence-based strength and conditioning programs...Civilian ContractorFull timeContract workTemporary workLocal areaHome office$72.7k - $106.7k
Job Description Position Summary This position supports the off-premise sales component of the distributor's market plan for their geographic area of responsibility. The assigned area of responsibility will be aligned with one or more of Constellation Brands Beer...Minimum wageFull timeRemote workShift work- QUALIFICATIONSUniversity degree with excellent academic record required; advanced degree preferred5+ years of professional experience in a hospital/clinical setting or direct provider consulting environmentInterest in procurement topics (medical/surgical supplies, pharmacy...ApprenticeshipEasy work
$110.87k - $153.18k
...Piper is a place you can engage in meaningful work and grow your career. Let’s see what we can achieve. Together.SummaryThe Senior Specialist, Telecom Practice Group, working in collaboration with and in support of the firm’s strategic initiatives, plays a central role...Full timeWork at officeRemote workWorldwideRelocationVisa sponsorshipRelocation package$100k - $140k
...200-year legacy and a shared passion for what’s next, this is the right place to build a fulfilling career.The Learning Systems specialist is responsible for the administration, optimization, and continuous improvement of the organization’s learning technology. This role...Full timeContract workWork at officeLocal area3 days per week$135k - $182.1k
Job Description:At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our clients, teammates, communities and shareholders every day.Being...Full timeWork at officeFlexible hoursShift workDay shift$75.1k - $112.6k
...opportunity to grow professionally in a dynamic, global environment, surrounded by forward-thinking peers.The Research Operations Specialist works to ensure members of the firm have access to accurate and current research materials. Responsibilities include performing...Full time$10k
Job Posting DescriptionPosition SummaryThe ECMO Specialist is enrolled and actively participating in the department’s ECMO Training Program. This role is responsible for developing and maintaining the skills necessary to proficiently and safely establish, manage, and control...Full timeTemporary workRelocation packageNight shiftRotating shiftWeekend workDay shift$80k - $120k
At WHOOP, we're on a mission to unlock and inspire performance for life. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.WHOOP is hiring an HRIS Systems Administrator to serve as the go-to resource for Workday...Full timeWork at officeRelocation$96k - $129k
Underwriting Specialist, Accident and Health Join us as an Underwriting Specialist to make more of your specialist expertise and experience.Make your mark in UnderwritingAIG underwriting teams help to find insurance solutions in areas including Financial Lines, Property...Full timeWork at office- OverviewAccenture helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed for organizations across industries. Our strategy is to be the reinvention partner of choice for our clients and lead ...Full timeLive inWork at officeLocal area
$83.2k - $124.8k
...who are #HappyatFoley, and we think you will be too.Foley is currently seeking a Business Development & Marketing (BD&M) Senior Specialist to join our team! The right candidate will have strong project management skills and assist the Business Law Department in managing...$125k - $135k
...the Health Information Technology field?We are excited to announce that currently we are looking for Health Information Technology Specialists to support an IQVIA pharmaceutical client partnershipThis individual will have the unique opportunity to be a part of multiple...Full timePart timeImmediate startWorldwideNight shift$90k - $110k
...team members to contribute in a larger capacity than is possible in typical positionsPosition DescriptionThe Regional Colorectal Specialist (RCS) is responsible for providing minimally invasive surgical solutions to hospitals with an immediate focus on our GelSeal® technologies...Local areaImmediate start$110k - $125k
...supported at the highest levels of investment standards and represented effectively both internally and externally.What is the SMA Specialist responsible for?The SMA Specialist acts as a subject matter expert and resource to Franklin Templeton’s Distribution organization...Local area$89.6k - $166.4k
Job Description Summary#LI-Onsite Internal Title: HSE SpecialistLocation: Cambridge, USASupport the implementation and continuous improvement of site HSE facility and contractor safety programs in alignment with local, regional, and global requirements. This position will...Full timeFor contractorsLocal areaRelocation package- QUALIFICATIONSBachelor’s degree required; advanced degree is a plus (if you are less than 8 years out of undergrad, please include your GPA on your resume)TS/SCI clearanceWillingness to travel upwards of 70%Outstanding record of academic and/or professional achievementDemonstrated...ApprenticeshipWork at officeEasy work
- We are looking for a Recertification Specialist to support property management operations in Boston, Massachusetts. This Long-term Contract position focuses on maintaining accurate resident records, coordinating recertification activities, and helping ensure compliance...Long term contract
- Job-ID32337861Reference26-00749 Job Summary:The Veeva Safety Specialist will be responsible for the implementation, administration, configuration, and ongoing support of Veeva Vault Safety solutions within a pharmaceutical or life sciences environment. This role involves...
$92k - $145k
About this role:Wells Fargo is seeking a Supervisory Control Specialist to join our Client Relationship Group (CRG) within Wealth and Investment Management. Learn more about the career areas and lines of business at wellsfargojobs.com.In this role, you will:Participate...Ongoing contractFull timeWork experience placementWork at officeImmediate start
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CQV Specialist. Be the first to apply!
Related searches
- candidate experience specialist Cambridge, MA
- gaming specialist Cambridge, MA
- information technology specialist Cambridge, MA
- leasing specialist Cambridge, MA
- infectious disease specialist Cambridge, MA
- wildlife specialist Cambridge, MA
- prevention specialist Cambridge, MA
- reading specialist Cambridge, MA
- government information specialist Cambridge, MA
- cash management specialist Cambridge, MA



