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Validation engineer Jobs in USA

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Validation engineer • usa

Last updated: 19 hours ago

Validation Engineer

Curium Live ForwardNoblesville, IN, United States, 46060
Permanent

The Validation Engineer is responsible for driving compliance, supporting validation projects and establishing risk-based validation strategy to enhance efficiency, regulatory, compliance and opera...Show more

Validation Engineer

Peregrine TeamPhiladelphia, PA, US
Full-time
Quick Apply

Peregrine Team is hiring a Validation Engineer to support equipment and process validation within a regulated pharmaceutical environment.This role ensures compliance with regulatory standards and s...Show more

Validation Engineer

KellyPetaluma, California, US
Permanent

Kelly Engineering is seeking a Validation Engineer to support a fast-paced medical device manufacturing environment in Petaluma, CA.This is a hands-on validation role focused on helping a growing t...Show more

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Validation Engineer

Katalyst HealthCares & Life SciencesCambridge, MA
Full-time

We are seeking a seasoned Validation Engineer with + years of experience in medical device or regulated manufacturing environments.Candidates must have strong hands-on expertise in IQ/OQ/PQ protoco...Show more

Validation Engineer

Medline Industries - Transportation & OperationsHartland, WI, US
Full-time

Job Summary Responsible for the validation of facility utilities, and equipment processes for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/2...Show more

Validation Engineer

JobotFairfield, New Jersey, US
Full-time

Validation Engineer Needed For Leading Medical Device Manufacturer This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your re...Show more

Engineer III - Validation

Porsche Engineering Services North America, Inc.Carson, United States of America
Full-time

The Engineer III, within the Complete Vehicle department at Porsche Engineering, is responsible for Complete Vehicle Validation and Assurance in the metropolitan area of California on public roads,...Show more

Validation Engineer

AgilentBoulder, CO, US
Full-time

Responsible for the execution of all qualification/validation activities, excluding process validation, at the Active Pharmaceutical Ingredient (API) manufacturing sites of Agilent Technologies Nuc...Show more

Validation Engineer

FlexBuffalo Grove, IL, US
Full-time

Job Posting Start Date 02-25-2026 Job Posting End Date 04-26-2026Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative produc...Show more

Associate Validation Engineer

Sterigenics U.S., LLCSalt Lake City, US
Full-time

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.Sotera Health Company is a ...Show more

Validation Engineer

Piper CompaniesLynwood, CA
Full-time

Responsibilities for the Validation Engineer .Oversee validation activities, including risk analysis, packaging, cleaning, and equipment qualification for new and updated processes.Develop, review,...Show more

Validation Engineer

AGCOHesston, KS, US
Full-time

Not everyone can claim to feed the world, but it is part of our every day.Behind everything we do for our farmers, there is one AGCO team making it happen.We are proud to put our curiosity to work,...Show more

Sensor Validation Engineer

Lunewave, Inc.Tucson, AZ, US
Full-time
Quick Apply

Sensor Validation Engineer Job Description Who we are:.Our products are geared towards a variety of markets including automotive, telecommunications, aerospace, and research for applications such a...Show more

Sr Validation Engineer

Sterling Engineering, Inc.Woodstock, IL, US
Permanent
Quick Apply

Full Employee Benefits Package that includes paid time off, paid holidays,.The Cleaning Validation Engineer is responsible for the planning, execution, documentation, and lifecycle support of clean...Show more

Validation Engineer

Intellectt INCSanta Clara, CA, United States
Full-time
Quick Apply

Job Title: Validation Engineer Location: Santa Clara, CA Duration: 06 Months Key Responsibilities: L...Show more

Validation Engineer

768 Flextronics International USA, Inc.Buffalo Grove, IL, USA
Full-time

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a.Reporting to the Quality Manager.Responsible for process validations to ensure that ...Show more

Validation Engineer

PrideStaffFairfield, NEW JERSEY, US
Full-time +1

Responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP).Requires a 4-yr engineeri...Show more

Validation Engineer

TSRSummit, NJ
Temporary

Manages projects of varying scope and complexity.Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, a...Show more

Validation Engineer

Precision Medicine GroupSan Diego, California, United States
Full-time

Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization.As a leader within the life ...Show more

Validation Engineer

Validation Engineer

Curium Live ForwardNoblesville, IN, United States, 46060
30+ days ago
Job type
  • Permanent
Job description

Summary of Position

The Validation Engineer is responsible for driving compliance, supporting validation projects and establishing risk-based validation strategy to enhance efficiency, regulatory, compliance and operational excellence including Data Integrity for GMP manufacturing and QC Laboratory systems at multi facilities of Curium located in North America. The candidate will support the execution of validation activities for one or more of the following areas: Cleaning Validation and Facility, Utility, Equipment, and System Qualification (CTUs, RABS, Isolators, Fill-Finish Lines, Lyophilization, Autoclaves, Vial Washers, Dehydrogenation ovens, Visual Inspection and Packaging Labelers, WFI, Clean Steam, HVAC, Dehumidifiers).

Work Schedule: Monday – Friday 8am – 5pm

Essential Functions

  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, policies and procedures.
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
  • Track and communicate progress of work against milestones.
  • Hands on experience or knowledge of Cleaning Visual Inspection, Swabbing and rinse sampling of CIP systems or manufacturing equipment.
  • Support authoring and execution of validation life cycle activities such as URS, Criticality Assessments, Risk Assessments, FAT, SAT, IOPQ, PPQ, CSV, CV, PV, Periodic Reviews and re-qualifications) for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing and packaging environment.
  • Drive project management efforts for validation activities including project resource estimating, scheduling, risk assessment and overall coordination with cross functional teams including but not limited to: R&D, Operations, laboratory and Engineering.
  • Collect and review validation data and create validation summary reports including generation of exceptions or deviations, as needed.
  • Hands on experience with Kaye Validator, ValProbe, or Ellab temperature mapping equipment
  • Generate and review Change Control documents, site validation documents, and site Standard Operating Procedures.
  • Maintain current knowledge of federal and state regulations regarding validation and cGMPs and proactively champion validation initiatives to meet same.
  • Assist in training and development of validation personnel.
  • Perform periodic SOP review and revisions to assure alignment with corporate and regulatory requirements.
  • Coordinate or author investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues.
  • Support the validation function during internal and external audits, providing expert insights and quick resolution to observations or deviations.
  • Must be able to travel approximately 25% within US to support validation activities at multiple Curium facilities.

Requirements

  • Bachelors Degree in related life sciences or Engineering required. Work experience will be considered in lieu of degree.
  • Three or more years of relevant experience required.
  • Minimum of two years of validation experience with sterile processes required.
  • Working knowledge of global cGMPs (to include EU standards), Validation Life Cycle and pharmaceutical manufacturing requirements.
  • Familiarity with the Sterile manufacturing and packaging facilities and operations.
  • Familiarity with Radiopharmaceutical processing is highly preferred.
  • Results-oriented, able to make decisions and prioritize work per business needs in a fast-paced environment.
  • Strong written and verbal communication skills, problem solving, organization and time management skills.
  • Strong computer competencies including proficiency in Microsoft suite products, statistical software and Quality Documentation Management software.
  • Primary job location is in Noblesville, but occasional travel is required to Missouri to support the qualification activities at our Maryland Heights facility.


Working Conditions:

  • Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
  • Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
  • Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
  • May be required to sit or stand for long periods of 8+ hours a day while performing duties.
  • Must possess good hand-eye coordination; close attention to detail is required.
  • Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
  • Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
  • Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.