Manufacturing Validation Associate II Job at Baxter (Round Lake)

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 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

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

Associate Scientist II - Chemical Characterization

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Round Lake

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemistry such as analytical or organic chemistry with 3+ years
Master’s degree in chemistry such as analytical or organic chemistry with at least 0 + years
Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations
Ability to organize complex information and demonstrated attention to detail
Demonstrates Quality and compliance oriented accomplishments
Possess basic understanding of analytical chemistry (e.g., wet chemistry, chromatography, and spectroscopy), including theoretical knowledge and practical experience
E&L testing knowledge a plus
Good knowledge of word processing, spreadsheets, table and graph generation, and use of applicable computer software
Ability to work independently as well as in a collaborative team environment
Possess strong time management and project management skills

Job Responsibility

Employ appropriate techniques and methods such as LC-MS, GC-MS, and/or ICP-MS and associated sample preparation to successfully and independently execute impurities studies and continuous improvement initiatives
Manage laboratory utilization by participating in detailed planning and management of the implementation as applicable
Manage sample and chemical inventories- labeling, receipt, and supply
Manage electronic lab notebook organization, templates, best practices and compliance
Perform notebook reviews for general laboratory operations and data acquisition
Oversee ownership of high-end instruments which includes scheduling and coordination of instrumentation and equipment (validation, qualification and maintenance schedules)
Contribute to and support the chemical characterization of manufacturing materials, drug packaging and medical devices according to global standards (USP <1665>, <661.2>, <1663> and <1664>, and ISO 10993-18)
Anticipate risks, issues, and opportunities, work independently to make sound technical recommendations regarding projects, and collaborate with a team to devise mitigations and solutions

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

Associate Scientist II - Chemical Characterization

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Round Lake

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemistry such as analytical or organic chemistry with 3+ years
Master’s degree in chemistry such as analytical or organic chemistry with at least 0 + years
Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations
Ability to organize complex information and demonstrated attention to detail
Possess basic understanding of analytical chemistry (e.g., wet chemistry, chromatography, and spectroscopy), including theoretical knowledge and practical experience
Good knowledge of word processing, spreadsheets, table and graph generation, and use of applicable computer software
Ability to work independently as well as in a collaborative team environment
Possess strong time management and project management skills
Working knowledge of industry regulations ISO, MDR, ICH, GxP, USP, or other regulated environments

Job Responsibility

Employ appropriate techniques and methods such as LC-MS, GC-MS, and/or ICP-MS and associated sample preparation to successfully and independently execute impurities studies and continuous improvement initiatives
Manage laboratory utilization by participating in detailed planning and management of the implementation as applicable
Manage sample and chemical inventories- labeling, receipt, and supply
Manage electronic lab notebook organization, templates, best practices and compliance
Perform notebook reviews for general laboratory operations and data acquisition
Oversee ownership of high-end instruments which includes scheduling and coordination of instrumentation and equipment (validation, qualification and maintenance schedules)
Contribute to and support the chemical characterization of manufacturing materials, drug packaging and medical devices according to global standards (USP <1665>, <661.2>, <1663> and <1664>, and ISO 10993-18)
Anticipate risks, issues, and opportunities, work independently to make sound technical recommendations regarding projects, and collaborate with a team to devise mitigations and solutions

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

Associate Scientist II - Chemical Characterization

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

United States , Round Lake

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemistry such as analytical or organic chemistry with 3+ years
Master’s degree in chemistry such as analytical or organic chemistry with at least 0 + years
Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations
Ability to organize complex information and demonstrated attention to detail
Demonstrates Quality and compliance oriented accomplishments
Possess basic understanding of analytical chemistry (e.g., wet chemistry, chromatography, and spectroscopy), including theoretical knowledge and practical experience
Good knowledge of word processing, spreadsheets, table and graph generation, and use of applicable computer software
Ability to work independently as well as in a collaborative team environment
Possess strong time management and project management skills
Working knowledge of industry regulations ISO, MDR, ICH, GxP, USP, or other regulated environments

Job Responsibility

Employ appropriate techniques and methods such as LC-MS, GC-MS, and/or ICP-MS and associated sample preparation to successfully and independently execute impurities studies and continuous improvement initiatives
Manage laboratory utilization by participating in detailed planning and management of the implementation as applicable
Manage sample and chemical inventories- labeling, receipt, and supply
Manage electronic lab notebook organization, templates, best practices and compliance
Perform notebook reviews for general laboratory operations and data acquisition
Oversee ownership of high-end instruments which includes scheduling and coordination of instrumentation and equipment (validation, qualification and maintenance schedules)
Contribute to and support the chemical characterization of manufacturing materials, drug packaging and medical devices according to global standards (USP <1665>, <661.2>, <1663> and <1664>, and ISO 10993-18)
Anticipate risks, issues, and opportunities, work independently to make sound technical recommendations regarding projects, and collaborate with a team to devise mitigations and solutions

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

Plastic Pour Bottle Manufacturing Supervisor II

In the role of Plastic Pour Bottle Manufacturing Supervisor II at our Cleveland,...

Location

United States , Cleveland

Salary:

80000.00 - 100000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree preferred
minimum Associate degree or equivalent experience in a technical field required
A minimum of 3 years in manufacturing
at least 1 year in a supervisory role
Proven track record of interpersonal and leadership skills
Comprehensive understanding of related manufacturing equipment and processes
Ability to prioritize multiple tasks in a manufacturing plant setting
Strong professional writing skills and ability to produce technical reports
Ability to understand GMPs and other applicable regulatory guidelines
Strong assessment and troubleshooting skills

Job Responsibility

Provide mentorship, support, direction, and leadership through effective interactions with all personnel during daily operations
Supervise day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities
Interview, hire, mentor, motivate, develop, recognize, and manage performance of direct reports
Review, approve, and run documentation for batch and system records
Assist in product release for distribution
Identify, initiate, and facilitate continuous improvements, lean manufacturing activities, and initiatives
Ensure resources and raw materials are applied in the most efficient and productive manner possible
Develop training content and facilitate and verify appropriate training for employees
Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements
Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap

What we offer

Medical, Dental, and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Paid Parental Leave
Tuition Reimbursement
Employee Stock Purchase Plan (ESPP)
Flexible Spending Accounts
educational assistance programs
family and medical leaves of absence
commuting benefits

Fulltime

Industrial Engineer II - Lean Transformation

Facilitate and coordinate efforts to ensure Lean Transformation initiatives are ...

Location

United States , Irving

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Industrial Engineering, Industrial & Systems Engineering, Manufacturing Engineering, or Health Systems Engineering from an ABET-accredited university
1 year of process improvement experience in a professional setting required
3 years of professional experience preferred
Demonstrated ability to apply industrial engineering, Lean, and continuous improvement methodologies to analyze and improve operational processes
Hands-on experience conducting time studies, workload assessments, and capacity analysis
Proficient in Microsoft Office Suite tools: Excel, Word, PowerPoint, Visio, Project, and Outlook
Ability to independently execute moderate-complexity improvement projects within defined scope and timelines
Skilled in developing clear process documentation, standard work, and performance metrics
Excellent written and oral communication skills
Able to communicate effectively, display confidence, act decisively, and work well under pressure

Job Responsibility

Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders
Create a productive and engaging environment for associates, ensuring that discussions are structured, focused, and lead to actionable outcomes
Lead and coordinate Lean projects, workshops, Rapid Improvement Events (RIE), Kaizens, meetings and team discussions
Collects, validates, and analyzes data to identify areas of improvement to draw conclusions for recommendations
Identifies root cause to build and execute corrective action tasks in improvement plans
Summarizes and presents gap analysis to various levels throughout the organization
Collaborates on plan formation with other engineers for future operational and analytical development
Leverage Lean principles to identify opportunities to increase efficiency and reduce waste
Identifies barriers to success and implements change management support
Facilitates operational improvement activities with associates

Fulltime

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