CrawlJobs Logo

Validation Associate II

https://www.baxter.com/ Logo

Baxter

Location Icon

Location:
United States , Round Lake

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

80000.00 - 110000.00 USD / Year

Job Description:

This position is responsible for the development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA and client/customer compliance audits.

Job Responsibility:

  • Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities
  • Interpret and apply regulatory requirements concerning validation activities
  • Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
  • Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required
  • Serves as a project lead for projects of intermediate scope with cross-functional teams
  • Support regulatory inspections and responses as required
  • Able to prioritize workload and tasks
  • Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations

Requirements:

  • BS Degree in Science, Engineering or Math with 2 or more years of experience
  • Master's Degree with 1 or more years of experience
  • At least 2 years of direct experience with writing and executing validation protocols is preferred
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation
  • Good interpersonal/communication/influencing/negotiation skills
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Proficient in Microsoft Word and Excel, computer software
  • Some experience with statistical software helpful
  • Direct or indirect industry knowledge
  • Ability to work independently or in teams
  • Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces
  • Ability to work at least 5 days onsite
  • Must not be allergic to Cephalosporins or Penicillin
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • educational assistance programs
  • paid holidays
  • paid time off ranging from 20 to 35 days based on length of service
  • family and medical leaves of absence
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits

Additional Information:

Job Posted:
March 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Validation Associate II

Clinical Research Associate II

Clinical Research Associate - Remote - FSP. ICON plc is a world-leading healthca...
Location
Location
Greece , Athens
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in a scientific or healthcare-related field
  • Minimum of 2 years of experience as a Clinical Research Associate
  • In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
  • Strong organizational and communication skills, with attention to detail
  • Ability to work independently and collaboratively in a fast-paced environment
  • Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license
Job Responsibility
Job Responsibility
  • Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
  • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
  • Collaborating with investigators and site staff to facilitate smooth study conduct
  • Performing data review and resolution of queries to maintain high-quality clinical data
  • Contributing to the preparation and review of study documentation, including protocols and clinical study reports
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
  • Fulltime
Read More
Arrow Right
New

Manufacturing Validation Associate II

Location
Location
United States , Round Lake
Salary
Salary:
88000.00 - 121000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
  • 2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
  • Ability to work at least 5 days onsite in the plant
  • Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
  • Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
  • Good interpersonal/communication/influencing/negotiation skills
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful
  • Direct or indirect industry knowledge
Job Responsibility
Job Responsibility
  • Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
  • Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
  • Lead and support cleaning validation activities, including protocol execution and sampling activities
  • Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
  • Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
  • Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
  • Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
  • Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
  • Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
  • Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Drafter II

KDM Engineering is seeking a self-motivated Drafter who will prepare clear, comp...
Location
Location
United States , Chicago
Salary
Salary:
Not provided
kdmengineering.com Logo
KDM Engineering
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate of Applied Science degree (AAS) and Certification in AutoCAD or the equivalent education or experience
  • 2+ years of applicable experience
  • Ability to communicate effectively and clearly, both verbally and in written form
  • Comfortable in a self-directed environment
  • Detail oriented, organized, able to multitask, prioritize and meet deadlines
  • Be a self-starter, ability to perform duties with limited supervision and be a cooperative team player
  • Versatility, flexibility, and a willingness to work within constantly changing priorities
  • Must be willing to comply with all pre-employment screening, including but not limited to, drug testing, reference verification, education and employment verification, and background screening
  • Must be legally authorized to work in the U.S.
  • Possess a valid Driver’s License
Job Responsibility
Job Responsibility
  • Analyze client requests/engineering sketches
  • Understand the use of Adobe Acrobat (pdf files), digital photographs (jpeg files), google earth, Microsoft Office products and internet search engines
  • Scale engineering drawings using AutoCAD
  • Calculating lay outs of right-of-way and/or street dimensions and angles
  • Creating preliminary and/or final sketch of proposed drawings
  • Modifying drawings based on engineer designs
  • Creating as-build drawings upon completion of project
  • Performing miscellaneous job-related duties as necessary
What we offer
What we offer
  • Competitive Base Salary
  • Comprehensive Benefits Package
  • Company Paid Holidays
  • Great Work-Life Balance
  • Fun and Flexible Work Environment
  • Organization with People-First Mentality
  • Dynamic Leadership Team
  • A Culture that Values Your Input
  • Positive team environment
  • Competitive salaries
  • Fulltime
Read More
Arrow Right
New

Network Engineer III

We are seeking talented, experienced Network Engineering professionals to join t...
Location
Location
United States , Huntsville
Salary
Salary:
79119.18 - 190122.20 USD / Year
arcfield.com Logo
Arcfield
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Network Engineering, Computer Engineering, Computer Science, or a related technical field with 5-7 years of experience, MS 3-5 years of experience, PhD 0-2 years of experience
  • Valid Security+ or DoD Directive 8570.01 IAT Level II certification
  • Valid Cisco Certified Network Associate (CCNA) certification or higher
  • 3+ years of general work experience designing, developing, and implementing network architecture
  • 3+ years of experience configuring and troubleshooting routers, switches, and associated network protocols such as OSPF, EIGRP, and Rapid PVST
  • 3+ years of experience supporting network security hardware and solutions like Cisco ASA firewalls, IPSEC, Access Control Lists (ACLs), and Network Address Translation (NAT)
  • Experience with network analysis tools such as SolarWinds and Wireshark
  • Experience with Visio
  • Possess and maintain a Secret clearance
Job Responsibility
Job Responsibility
  • Develop and deploy communications architectures to meet dynamic mission requirements across multiple ranges
  • Design, install, maintain, and repair deployable communications sites, ensuring optimal performance and reliability
  • Route data with type 1 encryption between various ranges and sites, ensuring secure and reliable communication
  • Configure and secure enterprise services, including routers, switches, firewalls, and access control solutions
  • Troubleshoot and optimize routing protocols such as OSPF and EIGRP, along with QoS, VPNs, and Spanning Tree Protocol
  • Interface with analog voice communications systems across multiple locations to ensure seamless integration
  • Maintain and update systems with patches to comply with Risk Management Framework (RMF) Information Assurance Vulnerability Management (IAVM) requirements
  • Collaborate with systems administrators on other standalone systems to improve their network architecture
  • Develop comprehensive system documentation, including standard operating procedures and network drawings
  • Regularly report project status to the Lead Network Engineer and Senior Management
What we offer
What we offer
  • Health Insurance
  • Life Insurance
  • Paid Time Off
  • Holiday Pay
  • Short Term and Long-Term Disability
  • Retirement and Savings
  • Learning and Development opportunities
  • wellness programs
  • Fulltime
Read More
Arrow Right
New

Network Engineer III

We are seeking talented, experienced Network Engineering professionals to join t...
Location
Location
United States , Huntsville
Salary
Salary:
Not provided
arcfield.com Logo
Arcfield
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Network Engineering, Computer Engineering, Computer Science, or a related technical field with 5-7 years of experience, MS 3-5 years of experience, PhD 0-2 years of experience
  • Valid Security+ or DoD Directive 8570.01 IAT Level II certification
  • Valid Cisco Certified Network Associate (CCNA) certification or higher
  • 3+ years of general work experience designing, developing, and implementing network architecture
  • 3+ years of experience configuring and troubleshooting routers, switches, and associated network protocols such as OSPF, EIGRP, and Rapid PVST
  • 3+ years of experience supporting network security hardware and solutions like Cisco ASA firewalls, IPSEC, Access Control Lists (ACLs), and Network Address Translation (NAT)
  • Experience with network analysis tools such as SolarWinds and Wireshark
  • Experience with Visio
  • Possess and maintain a Secret clearance
Job Responsibility
Job Responsibility
  • Develop and deploy communications architectures to meet dynamic mission requirements across multiple ranges
  • Design, install, maintain, and repair deployable communications sites, ensuring optimal performance and reliability
  • Route data with type 1 encryption between various ranges and sites, ensuring secure and reliable communication
  • Configure and secure enterprise services, including routers, switches, firewalls, and access control solutions
  • Troubleshoot and optimize routing protocols such as OSPF and EIGRP, along with QoS, VPNs, and Spanning Tree Protocol
  • Interface with analog voice communications systems across multiple locations to ensure seamless integration
  • Maintain and update systems with patches to comply with Risk Management Framework (RMF) Information Assurance Vulnerability Management (IAVM) requirements
  • Collaborate with systems administrators on other standalone systems to improve their network architecture
  • Develop comprehensive system documentation, including standard operating procedures and network drawings
  • Regularly report project status to the Lead Network Engineer and Senior Management
  • Fulltime
Read More
Arrow Right

Validation Associate II

This position is responsible for the development and the execution of projects w...
Location
Location
United States , Round Lake
Salary
Salary:
80000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS Degree in Science, Engineering or Math with 2 or more years of experience
  • Master's Degree with 1 or more years of experience
  • At least 2 years of direct experience with writing and executing validation protocols is preferred
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation
  • Good interpersonal/communication/influencing/negotiation skills
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Proficient in Microsoft Word and Excel, computer software
  • Some experience with statistical software helpful
  • Direct or indirect industry knowledge
Job Responsibility
Job Responsibility
  • Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities
  • Interpret and apply regulatory requirements concerning validation activities
  • Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
  • Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required
  • Serves as a project lead for projects of intermediate scope with cross-functional teams
  • Support regulatory inspections and responses as required
  • Able to prioritize workload and tasks
  • Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Validation Associate II

This position is responsible for the development and the execution of projects w...
Location
Location
United States , Round Lake
Salary
Salary:
80000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS Degree in Science, Engineering or Math with 2 or more years of experience
  • Master's Degree with 1 or more years of experience
  • At least 2 years of direct experience with writing and executing validation protocols is preferred
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation
  • Good interpersonal/communication/influencing/negotiation skills
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Proficient in Microsoft Word and Excel, computer software
  • Some experience with statistical software helpful
  • Direct or indirect industry knowledge
Job Responsibility
Job Responsibility
  • Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities
  • Interpret and apply regulatory requirements concerning validation activities
  • Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
  • Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required
  • Serves as a project lead for projects of intermediate scope with cross-functional teams
  • Support regulatory inspections and responses as required
  • Able to prioritize workload and tasks
  • Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Validation Associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Round Lake
Salary
Salary:
80000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS Degree in Science, Engineering or Math with 2 or more years of experience
  • Master's Degree with 1 or more years of experience
  • At least 2 years of direct experience with writing and executing validation protocols is preferred
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation
  • Good interpersonal/communication/influencing/negotiation skills
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Proficient in Microsoft Word and Excel, computer software
  • Some experience with statistical software helpful
  • Direct or indirect industry knowledge
Job Responsibility
Job Responsibility
  • Development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes
  • Validation activities include research, protocol writing/execution and final report generation
  • Investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented
  • Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA and client/customer compliance audits
  • Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities
  • Interpret and apply regulatory requirements concerning validation activities
  • Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
  • Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right