Validation Specialist

Katalyst Healthcares and Life Sciences

Denver, CO

Job Description:

This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area.
This role will be supporting validation leads to help ensure the required deliverables and testing are complete according to the Client CSV SOP.
Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel.
Experience with current digital validation tools is required, use of AI as an accelerator is a plus.
Overall a solid CSV background and having a strong work ethic in an aggressive project setting will be key to being successful in this role.

Responsibilities:

Support creation, review, and approval of all CSV deliverables for custom in-house solutions.
Maintain close communication with stakeholders and team members to keep apprised of CSV needs, interpretation of requirements, impacts on compliance of an application, project status, and other relevant issues
bility to create documents to an existing document standard
Obtain and respond to review by Business, IT, and Quality stakeholders
Follow SOPs and industry best practices
dvanced knowledge of complete MS Office suite and Visio.
Firm understanding of technology platforms as needed for project.
Experience with electronic document management systems (e.g. Qumas, SharePoint etc.); application development and lifecycle management (e.g. ALM, Jira, etc.); and IT service management systems (e.g. ServiceNow)
Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Familiarity with using AI as an accelerator for creation and review of documents and testing.

Requirements:

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline.
8-10+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
5+ years of experience in Data Integrity/ALCOA+ principles.
5+ years of experience with CSA principles.
5+ years of experience with technical writing.
Working knowledge of GMP, GLP, and GAMP 5 principles.
Strong understanding of FDA regulations, ICH guidelines, and EU Annex 11 (as applicable).
Experience developing, executing, and reviewing:
Validation protocols and reportsRisk assessments (FMEA, impact assessments)SOPs, deviation investigations, and CAPAs.
bility to support regulatory inspections and audits (FDA, EMA, internal, or client audits).
Strong technical writing skills with attention to detail and data integrity.
Proficiency with common pharmaceutical documentation systems and tools (e.g., EDMS, change control systems).
Excellent organizational, communication, and cross functional collaboration skills.
Cross-functional experience in one or more regulated areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
bility to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
Excellent interpersonal skills, including written and verbal communication.
Strong sense of ethics, diplomacy and discretion.
Commitment to Quality.
Strong critical thinking to analyze complex situations and discern critical issues.
ble to work effectively with highly-matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable and delivering on commitments.
Excellent team player attitude.
bility to manage competing priorities.

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the Validation Specialist in Denver, CO vacancy

Validation Engineering
...Job TitleSupport cleaning validation activities, protocol execution, sampling, and documentation.Perform temperature mapping and requalification of controlled temperature units.Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.Support...
Suggested
Katalyst HealthCares & Life Sciences
Denver, CO
4 days ago
Data Solutions & Validation Sr. Specialist
$106k - $125k
...thinking, advanced analytics, and cutting-edge technology to build a best-in-class Financial Crimes Program.As the Senior Specialist, Model Validation & Analytics, you will play a key role in this mission by executing the validation, testing, tuning, and optimization of...
Suggested
Work at office
Flexible hours
Shift work
3 days per week
Robinhood Financial
Denver, CO
3 days ago
Validation Engineering
$101k - $178.14k
...verification of FPGA and/or ASIC devices\. - Experience in ASIC / FPGA life cycle $architecture, design, simulation, verification, validation, integration & test$\. - FPGA/ASIC design experience is a plus\. - Experienced in scripting such as Perl, TCL, Python\. -...
Suggested
Full time
Temporary work
Work experience placement
Work at office
Remote work
Relocation
Flexible hours
Shift work
Lockheed Martin Corporation
Denver, CO
3 days ago
Senior Surface Mining Engineer
$117.8k - $176.8k
At Stantec, we help deliver the critical minerals needed to power our world, from the cars we drive to the infrastructure powering our communities. And we don’t just design the largest, deepest, and most technically challenging mines in the world—we do it sustainably. We...
Suggested
Full time
Temporary work
Part time
Casual work
Work at office
Local area
Remote work
Flexible hours
Stantec
Denver, CO
3 days ago
Senior ML Validation Engineer
$144.7k - $261.3k
..., California, United States of America Remote - United States Full time JR-202604934 Job Description The Senior ML Validation Research Engineer will lead applied machine learning research focused on improving verification and validation of ML components used...
Suggested
Full time
Local area
Remote work
Work from home
Flexible hours
General Motors
Denver, CO
4 days ago
Product Validation Engineer
...Product Validation EngineerLocation: Denver COType: FTE/ContractDevelop firmware test plans and implement test cases based on requirements.Automate test cases and develop test tools on various hardware platforms.Co-ordinate with development teams and multi-functional...
Work experience placement
Keylent Inc
Denver, CO
4 days ago
Corrosion Engineer
$117.09k - $158.84k
Structural Integrity Associates is looking for a Senior Coatings & Corrosion Consultant to advance their coatings and linings services in the nuclear power industry. You will lead projects, engage with clients, and support R&D programs for critical plant assets. This role...
Structural Integrity Associates
Denver, CO
3 days ago
Engineering automation and manufacturing
WHO WE ARE: Accenture is a leading solutions and services company that helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed across the enterprise, bringing together the talent of our approximately...
Full time
Work experience placement
Live in
Work at office
Local area
Accenture
Denver, CO
2 days ago
Senior Surface Water Engineer
$97k - $160k
This OpportunityWSP is seeking a Senior Surface Water Engineer to join our Denver (South Colorado Boulevard) office. This position is intended for an engineer with approximately 5-7 years of experience who has developed strong technical capabilities in hydrology, hydraulics...
Work at office
Local area
WSP Group
Denver, CO
2 days ago
Surface Mining Automation Engineer
$166.83k - $245.34k
DescriptionSurface Mining Automation Engineer Worley Consulting GroupAmericasWorley Consulting. Be part of the solution.Worley Consulting is a global group of consultants, scientists, engineers, and digital experts dedicated to solving the world’s critical infrastructure...
Full time
Work at office
Local area
Remote work
Overseas
Flexible hours
3 days per week
Worley
Denver, CO
4 days ago
Test engineering tech
$90k - $105k
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protected individuals as defined by 8 U.S.C. 1324b(a)(3...
Permanent employment
Full time
Contract work
Work experience placement
Local area
Cesiumastro
Westminster, CO
16 hours ago
Senior Test Engineer
$125k - $170k
...PREFERRED SKILLS AND EXPERIENCE Master's degree in engineering. Familiarity with systems engineering principles and test validation traceability. Expertise with data acquisition, test automation, and scripting (LabVIEW, Python, MATLAB). Knowledge of test...
Permanent employment
Full time
True Anomaly
Denver, CO
16 hours ago
Test engineering tech
$65k - $90k
...plans, reports, and data packages aligned with engineering requirements and program needs Execute test procedures, collect and validate test data, and ensure adherence to safety, quality, and configuration control standards Analyze test results, document...
Permanent employment
Full time
Work at office
True Anomaly
Denver, CO
16 hours ago
Test Engineer Journeyman
$73k - $110k
...seeking a Test Engineer (Journeyman) to support a space weather satellite mission operations program , focused on integration and validation of mission-critical systems. This role is ideal for someone with a strong foundation in testing methodologies and a passion for...
Full time
Red Canyon Engineering
Aurora, CO
16 hours ago
Acoustics Engineering
...keeping responsibilities. Maintain proficiency and understanding in the use of scientific instruments and sampling protocols to ensure valid sample collection and reliable data analysis in compliance with regulations. Maintain high ethical standards in the performance of...
For contractors
Work experience placement
For subcontractor
Hanchey
Denver, CO
4 days ago
Manufacturing and Test Engineering Intern (Spring 2027)
Job Description Job Description Golden, CO | Full-Time | 12-15 Weeks Today, everything we send to space is constrained by what fits inside a rocket fairing. That's a fundamental bottleneck to building more capable spacecraft. Rendezvous Robotics is solving this ...
Permanent employment
Full time
Internship
Rendezvous Robotics
Denver, CO
26 days ago
Manufacturing and Test Engineering Intern (Fall 2026)
Job Description Job Description Golden, CO | Full-Time | 12-15 Weeks Today, everything we send to space is constrained by what fits inside a rocket fairing. That's a fundamental bottleneck to building more capable spacecraft. Rendezvous Robotics is solving this ...
Permanent employment
Full time
Internship
Rendezvous Robotics
Denver, CO
26 days ago
Test Automation Engineer
$90k - $190k
...accessibility, and security testing efforts in partnership with specialist teams. Define and report quality metrics such as coverage,... ...REST services, authentication patterns, and contract or schema validation. Experience integrating automated suites into a CI/CD pipeline...
Contract work
Work at office
Local area
Remote work
Visa sponsorship
Work visa
CapTech
Denver, CO
1 day ago
Test Engineer III, Secret Clearance
$95.9k - $178.1k
Requisition ID: 1319ERP Eligible?: YesERP amount: $1,000Relocation: PossibleType: ExemptShift: 1Clearance Prior to Start: SecretFinal Clearance: SecretPay Transparency: $95900.00 - $178100.00Experience Level: Experienced ProfessionalFT/PT/Casual: FullTimeDepartment: SpaceBusiness...
Full time
Temporary work
Work experience placement
Casual work
Work at office
Flexible hours
Lockheed Martin
Littleton, CO
3 days ago
Sr Manufacturing Engineer
$132.93k - $182.78k
Sierra Space CareersAt Sierra Space, we build the missions and systems that keep our world secure in the domain above Earth.Sierra Space team members share a spirit of innovation and collaboration and a belief that we can deliver on the boldest missions in space today....
Contract work
Work experience placement
Sierra Space
Englewood, CO
4 days ago
Manufacturing Engineer
$75.29k - $105.4k
Blue Origin InternshipAt Blue Origin, we envision millions of people living and working in space for the benefit of Earth. We're working to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our...
Permanent employment
Full time
Temporary work
Internship
Local area
Blue Origin
Denver, CO
4 days ago
Sr. Manufacturing Engineer
...development, line balancing, and flow optimization.Develop and maintain manufacturing documentation including work instructions, process validation records, and control plans.Collaborate with Quality, Operations, and Supply Chain teams to improve First Pass Yield (FPY), reduce...
RimePro Inc
Denver, CO
4 days ago
Entry level Manufacturing Engineering
...Security. This includes Manufacturing and Supply Chain support across all Blue Origin facilities.As part of a hardworking team of specialists, technicians, and engineers, you will provide technical expertise, leadership skills, and dedication to quality to positively...
Permanent employment
Temporary work
Internship
Local area
Flexible hours
Blue Origin
Denver, CO
4 days ago
Integration/Test Engineering: Remote
$86.9k - $198k
...and provide critical information to our warfighters. Your customer will trust you to not only test, analyze, evaluate, verify, and validate these systems leveraging established system requirements, but also identify areas requiring urgent mitigation up-front and early...
Full time
Contract work
Temporary work
Part time
For contractors
Work at office
Local area
Remote work
Booz Allen Hamilton
Aurora, CO
2 days ago
Manufacturing Engineering
$90k - $105k
Manufacturing EngineerDenver, CO Come Join Us!From apartments in New York to hospitals and stadiums in Dallas, libraries at prestigious universities to creating modern retail experiences, our teams contribute architectural glass and building products to projects that shape...
Oldcastle BuildingEnvelope
Denver, CO
4 days ago
Manufacturing Engineer III
Job Summary General Atomics Electromagnetic Systems (GA-EMS) is a supplier of advanced electromagnetic systems, related power equipment and other high technology products for a variety of government and commercial applications. These include products such as the design...
General Atomics
Centennial, CO
10 hours ago
Testing Engineering M/F
$68.9k - $131.1k
...role expands on foundational test engineering skills by contributing to automated testing, troubleshooting integration issues, and validating mission data flows. Work is performed using modern agile practices and routine interaction with multi‑discipline engineering...
Contract work
Temporary work
Work experience placement
Work at office
Remote work
Flexible hours
Raytheon
Aurora, CO
1 day ago
Senior Engineering, Test Engineering
$86.8k - $165.2k
...Sustainment and Development program in Aurora, CO. The role includes developing test strategies, guiding automated test solutions, validating interfaces, and supporting integration across multidiscipline teams. Work follows modern agile engineering methods and requires...
Contract work
Temporary work
Work experience placement
Work at office
Remote work
Flexible hours
Raytheon
Aurora, CO
1 day ago
Downstream Corrosion Engineer - Refinery Experience Only
...maintain assets overall integrity. Review design packages and validate materials selection based on applicable codes and standards.... ...codes such as API-571, API-580, API-570 and API-510. ~ NACE Specialist certification, NACE Senior Corrosion Technologist...
Full time
Aramco
Denver, CO
16 hours ago
Energy engineering
$102k - $120k
Job TitleEnergy EngineerJob Description SummaryJob DescriptionJob Description SummaryCushman & Wakefield is seeking a highly motivated Energy Engineer to join our growing team. This position requires a self-motivated individual with strong skills in data analysis, interpersonal...
Minimum wage
Full time
Work experience placement
Work at office
Local area
Flexible hours
Cushman & Wakefield
Denver, CO
2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Validation Specialist. Be the first to apply!