Validation Associate II Job at Baxter (Round Lake)

Clinical Research Associate II

Clinical Research Associate - Remote - FSP. ICON plc is a world-leading healthca...

Location

Greece , Athens

Salary:

Not provided

iconplc

Expiration Date

Until further notice

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

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

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

Manufacturing Validation Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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
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

Manufacturing Validation Associate II

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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

Drafter II

KDM Engineering is seeking a self-motivated Drafter who will prepare clear, comp...

Location

United States , Chicago

Salary:

Not provided

KDM Engineering

Expiration Date

Until further notice

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

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

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

Network Engineer III

We are seeking talented, experienced Network Engineering professionals to join t...

Location

United States , Huntsville

Salary:

79119.18 - 190122.20 USD / Year

Arcfield

Expiration Date

Until further notice

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

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

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

Network Engineer III

We are seeking talented, experienced Network Engineering professionals to join t...

Location

United States , Huntsville

Salary:

Not provided

Arcfield

Expiration Date

Until further notice

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

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