Validation Engineer

Katalyst Healthcares and Life Sciences

Kenosha, WI

Responsibilities:

Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.
The project is being driven by audit findings and identified gaps in the site's validation program. The primary focus will be equipment validation, especially around tanks used for drug substance mixing and drug product filling. The team needs to assess whether existing IOQ/OQ documentation is robust enough, identify gaps between OQ and PQ, and determine whether current qualifications can support performance qualification expectations.
The consultants will also support product-specific mixing study needs, including evaluating mixing from an equipment qualification perspective. This includes understanding tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps.
The team will also support smoke study execution in an aseptic processing environment. The site has a tunnel and two lyophilizers, so candidates should understand aseptic technique, equipment operation, and how to drive execution as a validation representative.
This role is execution-heavy, but the client also needs consultants who can perform gap assessments and provide guidance on validation strategies. The lead consultant should be able to drive the project, guide internal resources, manage execution, and keep the validation effort moving forward.

Requirements:

Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred. Equivalent hands-on validation experience can be considered.

Include Must Have:

Validation execution experience in a pharmaceutical, biotech, or aseptic manufacturing environment.
Equipment qualification experience.
Strong understanding of IOQ/OQ/PQ expectations.
bility to perform gap assessments.
Tank qualification experience.
Mixing study experience or strong understanding of equipment-based mixing qualification.
septic processing experience.
Smoke study experience or strong understanding of smoke study execution.
bility to support protocol execution and documentation.
bility to assess whether qualification packages are robust enough.
bility to identify validation gaps and recommend mitigation strategies.
bility to handle a strong personality and drive work forward without being timid.

Apply

Vacancy posted 5 days ago

Similar jobs that could be interesting for youBased on the Validation Engineer in Kenosha, WI vacancy

Validation Engineer
...Job Title Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The consultants... ...the validation effort moving forward. Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred...
Suggested
Katalyst HealthCares & Life Sciences
Kenosha, WI
2 days ago
Validation Engineering
$72.8k - $80.1k
...Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or equivalent experience) - 2–4 years' experience in commissioning and qualification in a regulated industry -...
Suggested
Worldwide
CAI
Kenosha, WI
8 days ago
Senior Validation Engineer
$87.15k - $94.6k
...Execution & Safety - Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety - Deliver C&... ...and Experience - Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute...
Suggested
For contractors
Worldwide
CAI
Kenosha, WI
4 days ago
Senior System Validation Engineer
...TITLE : Senior System Validation Engineer DUTIES: Validating complex embedded software interactions spanning propulsion, ADAS/AD, body, infotainment, and connected services. Lead integration and validation of embedded software at the component, subsystem, and full...
Suggested
Full time
Immediate start
Stellantis
Kenosha, WI
4 days ago
Manufacturing Engineer
$71.74k - $107.61k
...\n \n Mission \n \n \nWe are seeking a Manufacturing Engineer to join our team. The Manufacturing Engineer performs all functions... ...to define problems, collect data, establish facts, and draw valid conclusions. Interpretation of an extensive variety of technical...
Suggested
Hoerbiger
Waukegan, IL
26 days ago
Building Automation Systems Specialist
$49.2k - $84.33k
...written reports. Provides plans and control system documents to engineering for as-built drawings + Project site communication and... ...work overtime as needed + Must be 18 years of age and possess a valid driver's license with limited violations; must meet eligibility...
Permanent employment
Full time
For contractors
Work at office
Local area
Immediate start
Night shift
Siemens
Kenosha, WI
4 days ago
Senior Automation Engineering
...apply your relevant experience to a new industry, join our team as we help shape a brighter way forward. Sr. Automation Engineer - JLL What this job involves: We are seeking a Senior Automation Engineer to design, develop, and implement automation control...
Daily paid
Apprenticeship
Remote work
Jones Lang LaSalle IP, Inc.
Kenosha, WI
5 days ago
Manufacturing Engineering
$48.07 - $62.5 per hour
...Job Title: *URGENT* Manufacturing Engineer - Die Cast Experience *URGENT* Job Description We are seeking a skilled Manufacturing Engineer with strong experience in automotive die casting to support our daily production activities and contribute to new product...
Contract work
Temporary work
Work at office
Monday to Friday
Day shift
Actalent
Pleasant Prairie, WI
2 days ago
Senior Staff Engineer - Manufacturing Engineering
$113k - $143.95k
...solutions for today's world demands. Our product range includes engines, generators, power conversion, UPS systems, EV components and... ..., including budgeting, vendor selection, installation, and validation. Serve as the primary project manager for site-level...
Permanent employment
Full time
Local area
Rehlko
Kenosha, WI
4 days ago
Mechanics and Engineering (Hiring Immediately)
...Horizontal Construction Engineer Now Hiring Full and Part Time Positions Job Overview: You’ll be at the forefront of building essential infrastructure at home and abroad. You’ll operate powerful heavy machinery—bulldozers, excavators, graders, and cranes—to clear and...
Full time
Contract work
Part time
Immediate start
Relocation package
Flexible hours
United States Army
Kenosha, WI
1 day ago
Engineer
$100k - $120k
...of all entries within the Application Portfolio Management (APM) system of record. This role ensures that all application data is validated, consistently aligned to enterprise standards, and vetted with the appropriate technology and governance teams prior to any updates...
Tata Consultancy Services
Kenosha, WI
5 days ago
Manufacturing Robotics Automation Engineer
$95k - $125k
This Jobot Job is hosted by: Dana Stark Are you a fit? Easy Apply now by clicking the Apply button and sending us your resume. Salary: $95,000 - $125,000 per year A bit about us: We are a leading independent brokerage, delivering tailored insurance and risk ...
Local area
Jobot
Sturtevant, WI
4 hours ago
Nuclear Med Technologist
Nuclear Med Technologist MedPro Healthcare Staffing, a Joint Commission-certified staffing agency, is seeking a quality Nuclear Medicine Technologist for a contract with one of our top healthcare clients. The primary responsibility of the Nuclear Medicine Technologist...
Contract work
Local area
MedPro Healthcare Staffing
Kenosha, WI
3 days ago
Fall 2026 Graduate Engineer Internship/Co-op
$83.2k
...actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars. FALL 2026 GRADUATE ENGINEER As a Graduate Engineer, you will be responsible for working on creative solutions to real aerospace challenges. You will be...
Permanent employment
Full time
Work experience placement
Internship
Worldwide
Relocation
SpaceX
Kenosha, WI
4 days ago
Environmental Engineer
$104.7k - $143.99k
...Ocean Spray is hiring for a(n) Environmental Engineer! We're a team of farmers, thinkers, creators, and doers. Whatever your title, whatever your role - it always comes back to this: we're a farmer-owned co-op where everyone rolls up their sleeves to get the job done....
Temporary work
Work experience placement
Local area
Remote work
Long distance
Flexible hours
Ocean Spray Cranberries
Kenosha, WI
5 days ago
Remote- Systems Engineering -
$66k - $106k
...Description $66,000-$106,000 conversion salary Our cleint is looking to add two Systems Engineers to their organization. Their ideal scenario would be fore one person to be more heavily focused within the M365 tools, and the other be more of a "generalist" They...
Contract work
Temporary work
Work at office
Remote work
TEKsystems
Kenosha, WI
2 days ago
Civil and Environmental Engineering
$91.48k
...difference and change the world. Job Description With general direction, creates and signs off on basic to highly complex engineering designs involving site layout development, site grading and drainage, hydraulics and hydrology calculations, water distribution systems...
Work experience placement
H1b
Local area
CDM Smith
Kenosha, WI
5 days ago
Project Engineer
...facility located in Kenosha, known for delivering innovative, engineered solutions and motion transfer assemblies for the automotive industry... ...across product design, tooling development, process validation, customer coordination, and launch execution. The ideal candidate...
Work at office
Worldwide
Relocation package
Flexible hours
ASYST Technologies LLC
Kenosha, WI
4 days ago
Project Engineer I
$84.1k - $113.5k
...Project Engineer I Mortenson is currently seeking an experienced Project Engineer I with the ability to interact with a variety of... ...agency emails, calls, or solicitations are accepted without a valid agreement. Must be currently legally authorized to work in the...
Full time
Contract work
For subcontractor
H1b
Work at office
Flexible hours
Mortenson
Kenosha, WI
4 days ago
Project Engineer
$48.07 - $57.69 per hour
...EngineerJob Description We are seeking a dedicated Project Engineer to lead new product development and launch activities from concept... ...methods. Support tooling design, tooling tryouts, process validation, and production launch activities for molding and stamping...
Contract work
Temporary work
Work at office
Actalent
Kenosha, WI
2 days ago
Sales Engineering Tech
$72k - $100k
...Sales Engineer Every day, we get opportunities to make a positive impact on our colleagues, partners, customers and society. Together, we're pioneering the solutions of the future and unlocking the full potential of precious resources. Trusted to act on initiative,...
Alfa Laval Mid Europe Gmbh
Kenosha, WI
1 day ago
Civil Engineer - Water/Wastewater
$89.96k - $118.56k
...environmental, structural, mechanical, electrical and construction engineering. We succeed Together and believe that an inclusive workplace... ..., Biowin and/or other similar software packages is desired. Valid driver’s license and the ability to travel to projects sites are...
For contractors
Work at office
Work from home
Flexible hours
Clark Dietz
Kenosha, WI
17 hours ago
Packaging Specialist
Packaging Specialist Fulfillment Specialists of Wisconsin (FSWI) is a full service 3rd party logistics company providing warehousing, pick/pack and kitting/packaging operations for iconic local and national brands. Your role as a Packaging Specialist is to package orders...
Local area
Fulfillment Specialists of Wisconsin
Sturtevant, WI
5 days ago
Workplace Health and Safety Specialist 2026 - West (Recent and Upcoming Graduates)
Join Amazon’s mission to become Earth’s safest place to work! At Amazon, we’ve set the ambitious goal to become the benchmark of safety excellence across all industries in which we operate. As an entry-level Workplace Health & Safety Specialist (WHSS), you will be provided...
Full time
Work at office
Relocation package
Flexible hours
Shift work
Night shift
Weekend work
Amazon
Kenosha, WI
4 hours ago
Fulfillment Workplace Health and Safety Specialist Intern 2026
...Amazon’s fulfillment infrastructure • Learn about and work with other functional teams (Operations, RME (Reliability Maintenance & Engineering), Central Teams, Human Resources, Transportation Operations, and others) in the planning and execution of your assigned project....
Full time
Summer work
Internship
Work at office
Local area
Relocation
Relocation package
Shift work
Night shift
Weekend work
Amazon
Kenosha, WI
4 hours ago
Construction Project Engineer
$75k - $95k
...preparation of project schedules, budgets, and reports. Qualifications: Bachelor's degree in Construction Management, Civil Engineering, or a related field. 1-3 years of experience in construction or a similar role. Proficiency in project management software...
Temporary work
For subcontractor
Local area
Jobot
Kenosha, WI
5 days ago
Construction Project Engineer
$110k - $135k
Be the driving force behind high-profile construction projects in the Pacific Northwest, leading teams that build with purpose, precision, and pride. This Jobot Job is hosted by: Don Seawall Are you a fit? Easy Apply now by clicking the Apply button and sending us...
For contractors
For subcontractor
Local area
Jobot
Kenosha, WI
4 days ago
Packaging Associate
Job Description Job Description Multiple shifts available! Position Overview: Help manufacture the company's products, assist Production Supervisor and other personnel in all aspects of manufacturing, packaging, boxing, and shipping of company's products and OEM...
Shift work
Pinpoint Pharma LLC
Sturtevant, WI
5 days ago
Fire Protection Engineering
$91.48k
...environmental and infrastructure challenges, creating an unmatched experience for both our clients and our team. As a global engineering and construction firm, we partner with clients worldwide to develop innovative solutions that address today's needs and anticipate...
Work experience placement
H1b
Work at office
Local area
Remote work
Work from home
Worldwide
CDM Smith
Kenosha, WI
2 days ago
Manufacturing Engineer
...Foxconn Technology Group Company, is seeking a Manufacturing Engineer to develop and optimize manufacturing processes and design assembly... ...layouts, select appropriate equipment, and conduct process validation, while also assisting the Engineering Department as needed....
Full time
Temporary work
Foxconn WI
Mount Pleasant, WI
24 days ago

Do you want to receive more vacancies?

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