Validation Associate II Job at Baxter (Round Lake)

Validation Associate II

This position is responsible for the development and the execution of projects w...

Location

United States , Round Lake

Salary:

80000.00 - 110000.00 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
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

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

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

Validation Associate II

This position is responsible for the development and the execution of projects w...

Location

United States , Round Lake

Salary:

80000.00 - 110000.00 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
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

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

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

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:

80000.00 - 110000.00 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
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

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

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

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

Clinical Research Associate II / Senior Clinical Research Associate Large Pharma

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master or 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
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication skills in German and English
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex 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

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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 to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Clinical Research Associate II

CRA II and Senior CRA - Georgia - Sponsor Dedicated - Therapeutic area: Heart Fa...

Location

Georgia , Tbilisi

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 to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
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 Associate II, Reagents

Location

United States , Northbrook

Salary:

26.00 - 32.00 USD / Hour

Diasorin

Expiration Date

Until further notice

Requirements

Associate's Degree Associates degree in Chemistry, Life Sciences, Biotechnology, or Medical Technology related field required
3+ Years At least 3 years of relevant experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology industry required

Job Responsibility

Deliver manufacturing requirements and attainment of production schedule for standard inventory, build-to-order, and contract manufacturing market products
Deliver manufacturing requirements for qualification/processing of incoming materials, production intermediates, and stability samples
Deliver timely and accurate completion of manufacturing sections of process documentation and related business system transactions
Deliver timely and accurate completion of inventory cycle counts
Document non-conformances and participate in Material Review Board
Support design transfer and integration of new products and processes
Support process development and process improvements
Participate in the writing and execution of equipment and process validations
Support investigations and resolution of findings impacting the Reagent Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation
Deliver timely maintenance and calibration of assigned Manufacturing measuring and monitoring devices

What we offer

health benefits
retirement and financial wellbeing
time off programs
wellbeing support and perks
annual incentive program

Fulltime

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Validation Associate II

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Validation Associate II

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