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 Title Roles & Responsibilities: Support 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...
Suggested
Katalyst HealthCares & Life Sciences
Denver, CO
2 days ago
Verification Engineer
$130k - $200k
...generating and executing the Verification Test Plan and Verification Requirement Matrix Interact with Architecture, Design, SW and Validation teams Define new DV methodologies and improve existing ones Work on both ASIC and FPGA Space system projects...
Suggested
Temporary work
Work experience placement
Work at office
Remote work
Flexible hours
Pic-Time Ltd.
Denver, CO
1 day ago
Senior Software Quality & Validation Engineer
$75k - $95k
DescriptionWhat We Are Looking ForThe Software Quality Engineer leads global ownership and continuous improvement of the software validation process for Production Quality System Software (PQSS) within Quality and manufacturing environments. This role ensures validation...
Suggested
Work experience placement
Worldwide
Flexible hours
3D Systems
Littleton, CO
4 days ago
Industrial & Automotive Manufacturing Engineering Consultant
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...
Suggested
Full time
Work experience placement
Live in
Work at office
Local area
Accenture
Denver, CO
3 days ago
Principal Acoustics Consultant
$125k - $145k
...with engineers, scientists, planners, architects, environmental specialists, and other technical professionals.This is an opportunity for... ...to client sites and conduct or oversee field work as required.Valid driver's license.Working @ SLRWith us, there is no doubt you’ll...
Suggested
Permanent employment
Full time
Temporary work
For contractors
Work at office
RCS Global Group
Denver, CO
4 days ago
ASIC/FPGA Verification Engineer III
...clearance. Skills: Experience in the ASIC/FPGA lifecycle including architecture, design, simulation, verification, validation, integration, and testing. Knowledge of space-grade/qualified FPGAs and ASICs, and toolsets such as AMD/Xilinx Vivado or Microchip...
Full time
Flexible hours
AnySilicon
Denver, CO
1 day ago
Recruiter, Engineering & Manufacturing (Spark) (Contract)
$50 - $60 per hour
...seeking a highly motivated and results-driven Contract Recruiter to own niche technical hiring for Crusoe's Spark business. This is a specialist search role covering hard-to-fill manufacturing and engineering positions such as Manufacturing Engineering, Electrical...
Hourly pay
Full time
Contract work
Crusoe
Denver, CO
a month ago
Senior Manufacturing Engineering
$120k - $145.2k
Beehive Industries is dedicated to Powering American Defense by revolutionizing the design, development, and delivery of jet propulsion systems to support the warfighter. Through the integration of additive manufacturing, the company aims to meet the growing and urgent...
Temporary work
Work experience placement
Fleet Glass Services Inc
Centennial, CO
1 day ago
Manufacturing Engineer Intern
$25 - $30 per hour
As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare...
Hourly pay
Internship
Worldwide
Monday to Friday
LivaNova
Arvada, CO
1 day ago
Industrial Manufacturing Engineer
$80k - $90k
Industrial Manufacturing Engineer Base pay range: $80,000.00/yr - $90,000.00/yr An established and innovative manufacturing company is seeking an Industrial Engineer to join its team. This organization specializes in designing and producing high-quality products ...
Work at office
Confidential
Denver, CO
2 days ago
Senior Manufacturing Engineering
We’re hiring a Senior Manufacturing Manager to lead a multi-shift plastics manufacturing operation across injection molding, extrusion, and assembly . Key Responsibilities: Partner with Engineering, Quality, Finance & Supply Chain Oversee production budgets...
Shift work
Brightpath Associates LLC
Lakewood, CO
2 days ago
Engineering/ Manufacturing Tech
$109.37k - $150.38k
...improvement. Ability to lead cross-functional teams in process improvement projects. In-depth knowledge of manufacturing process validation and verification. Experience in developing and implementing manufacturing plans. Proficiency in using manufacturing...
Permanent employment
Contract work
Work experience placement
Front Door Defense
Centennial, CO
1 day ago
Senior Manufacturing Engineering
An innovative space technology company is seeking a Senior Manufacturing Engineer to support the development and production of next-generation robotic, mobility, and aerospace systems designed for extreme environments. This is an exciting opportunity to join a fast-paced...
Shift work
EVONA
Denver, CO
2 days ago
Senior Energy Engineer
$140k - $150k
About the Company Our client is a leading facility solutions provider dedicated to helping organizations improve building performance through innovative energy and infrastructure solutions. Their expertise spans HVAC system design, electrical upgrades, building automation...
Contract work
Remote work
Relocation
1 day per week
Kimmel and Associates
Denver, CO
4 days ago
Manufacturing Engineering Planning
$59.15k - $106.93k
Description Looking for an opportunity to make an impact? At Leidos, we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customers’ success. We empower our teams, contribute to our communities, and...
Work at office
Local area
Immediate start
Worldwide
Relocation
Leidos
Aurora, CO
5 days ago
Manufacturing Engineering
Quality Engineer Identify and document defects on the shop floor and trace similar issues in previously built units. Collect, analyze, and communicate non-conformance data effectively. Perform root cause analysis and investigate quality issues using structured problem...
Katalyst HealthCares & Life Sciences
Denver, CO
4 days ago
Senior Manufacturing Engineering
$102k - $127k
...productivity and product quality. The Senior Advanced Manufacturing Engineer will be responsible for developing, implementing, validating, maintaining, and improving manufacturing processes across machining, assembly, test, fabrication, and engineered plastics...
Permanent employment
Temporary work
Work experience placement
Flexible hours
Shift work
Day shift
Honeywell
Arvada, CO
5 days ago
Senior Manufacturing Engineering
About Dynamics Dynamics Inc. is a mature high‑tech start‑up that designs, manufactures and markets intelligent powered payment devices. We focus on introducing fast‑cycle innovation to top bank card issuers and our signature innovation is the world's first fully programmable...
Contract work
Work experience placement
MSC Industrial Direct
Denver, CO
3 days ago
Senior Manufacturing Engineering
$136k - $160k
ExoTerra is a world leader in solar electric propulsion systems and space exploration satellites. The company develops Hall Thrusters, propulsion modules, microsatellites and launch vehicle upper stages. We have been awarded multiple propulsion module and satellite contracts...
Permanent employment
ExoTerra Resource, LLC
Denver, CO
3 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
Lakewood, CO
11 days ago
Testing Engineering M/F
$115.6k - $254.2k
...results, readiness, and risks for release decisions.Collaborate with stakeholders to align requirements and define test strategies and validation components, including automation candidates.Support Government authorization processes, including test planning, control...
Contract work
Work experience placement
Flexible hours
CACI International
Denver, CO
2 days ago
Energy engineering
$110.5k - $130k
Job TitleEnergy EngineerJob 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 communication, and project management...
Minimum wage
Full time
Work experience placement
Work at office
Local area
Flexible hours
Cushman & Wakefield
Denver, CO
2 days ago
Industrial & Automotive Manufacturing Engineering Manager
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
Systems Engineer II â€“ Manufacturing Execution
$79.37k - $134.92k
Job Description At BAE Systems Space & Mission Systems (SMS) we develop and manufacture state-of-the-art RF & sensor technologies. If youd like to join our rapidly growing operations team in a mission to enable the warfighter to go forth bravely and return home safely...
Full time
Part time
Interim role
Work at office
Local area
Remote work
Worldwide
BAE Systems
Westminster, CO
4 days ago
Optical Manufacturing Engineer
$140k - $175k
...operation of the equipment and systems. Manage hardware configuration and maintain pedigree throughout the build and test phases. Validate assembly or operations safety procedures with the assistance of interdisciplinary engineers and safety personnel (HV, Oil Handling...
Permanent employment
Full time
Temporary work
Part time
Fixed term contract
Local area
Flexible hours
Xcimer Energy
Denver, CO
1 day ago
Principal Manufacturing Engineer
$145k - $175k
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Principal Manufacturing Engineer Full Time Technical Centennial, CO, US $145,000.00 To $175,000.00 Annually...
Full time
Work at office
Plasticmolding
Denver, CO
1 day ago
Electrical Engineer-Power Generation
$140k - $170k
About the Company Our client is a leading independent power generation platform that owns and operates more than 7 GW of utility-scale wind, solar, and natural gas generation assets across the United States . The company is focused on delivering reliable, sustainable...
Work at office
Remote work
Kimmel and Associates
Denver, CO
2 days ago
Senior Test Engineer, Grid-Scale Power Systems
...ON.energy in the Greater Denver area is seeking a Principal Test Engineer to lead end-to-end validation, de-risk product architectures, and orchestrate lab-based testing using HIL assets. You will coordinate with investigators, facilities, and field teams; design test...
Jobleads-US
Denver, CO
2 days ago
Automation Test Engineering
$90k - $190k
...accessibility, and security testing efforts in partnership with specialist teams. Define and report quality metrics such as coverage,... ...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
Worky Ltd
Denver, CO
1 day ago
Manufacturing Engineering
$115k - $140k
Job Description Job Description TITLE: Manufacturing Engineer FLSA STATUS: Exempt REPORTS TO: Manufacturing (Fabrication) Manager SUMMARY: The Manufacturing Engineer will be responsible for developing, improving, and optimizing forming and welding fabrication...
Work experience placement
Work visa
Relocation package
Advanced Technology Group
Westminster, CO
6 days ago

Do you want to receive more vacancies?

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