Packer
Melrose Park, IL job
Job SummaryOperates and maintains manufacturing packaging machinery, ensuring efficiency and quality in packaging processes, and replenishes materials as needed.ResponsibilitiesThe Specialist performs some or all of the following accountabilities as assigned: • Setting up, operating, maintaining, and troubleshooting manufacturing packaging machinery/equipment to ensure smooth production operations. • Operating manufacturing packaging equipment that packages materials or products by inserting them into containers or filling containers from spouts or chutes. • Monitoring, evaluating, and adjusting manufacturing packaging equipment to maximize quality and efficiency in the packaging process. • Restocking machines with necessary packaging materials to maintain continuous production flow. • Packing, wrapping, securing, or labeling containers as per the company's packaging standards and guidelines Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplySr. Executive Assistant
Deerfield, IL job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your role
As the Senior Executive Assistant, you will play a significant role on the team, providing dedicated support to the executive as well as one or two additional leaders and providing support for function as a whole. Exposure to senior levels of the organization, partnering with other Executive Assistants and Senior Executive Assistants, and external team members will be part of the day-to-day responsibilities.
What you'll be doing
* Provide dedicated support to 3 VP's, and, as needed, to their departments.
* Support a large organization within IT with multiple senior Director level employees.
* This exciting and challenging position will require working with other administrative staff both within the US and Globally.
* Will require independent thinking as well as partnering with team members.
* Global interaction and exposure to senior levels of the organization and external vendors will be part of the day to day.
* Broad versatile role with frequently changing priorities and deliverables.
* Represent Baxter on committees of a number of local charities including Habitat for Humanity.
* Coordinate schedules and assist in managing time of others.
* Coordinate domestic and international travel arrangements.
* Prepare expense reports and manage department credit line for purchases.
* Manage departmental purchase and ensure prompt and efficient flow of procure to pay process.
* Create/prepare correspondence and complex presentations.
* Assist with all meeting planning, including room set up, WebEx, and Tele-Presence / video conferencing.
* Develop and maintain database/spreadsheets.
* Manage staffing activities to include interviews, onboarding, contractors, and transfers.
* Apply and implement internal policies and provide training as needed.
* Involvement with project management/event coordination.
* Other duties as assigned by management.
What you'll bring
* High school diploma required.
* Bachelor's Degree highly preferred.
* Minimum of 5+ years of relevant experience. (2 or more years Baxter experience preferred).
* Advanced knowledge of computers/systems including, PowerPoint, Word, Excel, and Outlook. Knowledge of documentation management a plus.
* Demonstrated proficiency with Internet/Intranet applications and research.
* Excellent oral and written communication skills in order to effectively communicate with internal and external high-level executives.
* Previous experience with travel arrangements, expense reporting, meeting planning, and calendar management.
* Experience working with Global teams and/or Technical group support highly desired.
* Ability to multi-task, independently manage time and be detail oriented is a must.
* Support VP during times of increased activity, or as needed.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $64,000 to $88,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
QMS Specialist 1
Lombard, IL job
The Quality Management Systems Specialist will work with site employees to ensure bio Merieux's standards and requirements are met for various Quality systems. The position will act as administrator for batch record review, document control, training, and audits. Specialist will also support in the completion of higher criticality Quality tasks such as Quality Events, CAPAs, and metrics in association with bio Merieux's policies.
Primary Duties
* Perform Quality review of lot batch records for good documentation requirements and paperwork meets process specifications for product release
* Coordinate Change Request workflows and publish controlled documents within Document Control system, LLDC.
* Performs initial review of all Corporate driven procedure changes and manages Corporate Document Change Impact process
* Oversee the learning management system. Log completed training, generate reports and optimize training requirements for management
* Supports site continuous improvement activities
* Supports activities related to Quality Events and CAPA activities
* Coordinates internal and external audit schedule with stakeholders
* Provides input for improvement in the Quality Management System
* Support Quality Engineers with determination of Key Performance Indicators
* Perform all work in compliance with company quality procedures and standards
* Performs other duties as assigned
Minimum Qualifications:
* High School Diploma, GED or equivalent required
* 4 years of experience in quality management
* Background with implementation of process improvement programs
* Ccomputer skills including Microsoft Office Suite
* Knowledge of ISO 9001 preferred.
Knowledge, Skills and Abilities:
* Detail orientation to complete tasks without errors and produce high-quality
* Critical thinking, using logic and reason to analyze information and make decisions in the workplace
* Problem solving to find solutions to complex business challenges
* Strong interpersonal skills and great attention to detail are necessary
* Ability to manage indirect relationships and project successfully
* Elevate issues to management, when appropriate
* Must be able to handle multiple projects concurrently
Physical requirements:
* Ability to remain in stationary position, often standing, for prolonged periods
* Ability to ascend/descend stairs, ladders, ramps, and the like
* Ability to wear PPE correctly most of the day.
* Ability to operate heavy machinery
* Ability to adjust or move objects up to 50 pounds in all directions
Domestic travel - 10%
The estimated hourly wage range for this role based in Illinois is between $26.00 - 36.50. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.
Director, Manufacturing Operations
Melrose Park, IL job
Job SummaryThis position oversees management of all areas of Manufacturing operations to produce products and direct activities so that approved products are manufactured on-schedule within the quality standards and cost objectives. This position reports directly to the Plant Manager. Directly manages approximately 7 Production Manager(s) and/or Senior Manager(s) for the formulation, filling, and component preparation departments that support the terminal sterilization lines including terminal sterilizers and aseptic fill lines including lyophilizers. Indirectly manages approximately 400 Direct Labor Production Employees and Manufacturing Engineers.Responsibilities
POSITION RESPONSIBILITIES
Establishes and controls the processes and procedures for compounding, aseptic and terminal sterilization filling, component preparation, capping, and lyophilization.
Assist company officers and senior staff members in the development and formulation of long and short-range planning, policies, programs, and objectives.
Develop the manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
Achieve optimum employee levels with the least amount of overhead and raw material costs to meet annual budget.
Formulate and recommend manufacturing policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
Direct and monitor department managers and supervisors to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. Act as a liaison between department management/subordinate levels, as well as executive/Supervisor levels to inform personnel of communications, decisions, policies, and all matters that affect their performance and results.
Hire, train, develop, and evaluate staff. Take corrective action as necessary on a timely basis and in accordance with company policy. Ensure compliance with current federal and local regulations. Consult with Human Resources Department as appropriate.
Identify, recommend, and implement changes to improve productivity, reduce defects and reduce cost and scrap, monitor scrap and rework data. Direct the establishment, implementation and maintenance of production standards.
Direct and coordinate efforts to improve Right First Time execution, reduce deviations and manage the prioritization of the deviation writers to close deviations needed for on time batch release.
Direct and coordinate various programs essential to manufacturing procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.)
Initiate and coordinate major projects (e.g., plant layout changes, installation of capital equipment, major repairs, etc.)
Work effectively and relate well with others. Exhibiting a professional manner in dealing with others while working to maintain constructive working relationships
Keep current on information and technology affecting functional areas to increase innovation and ensure compliance
Participate in the preparation and presentation of site related business metrics and performance metrics, such as Line OEE achievement and production output, to upper level management.
Support regulatory inspections and company audits as the Subject Matter Expert for the assigned departments under your control and engage direct reports as needed for support.
Perform miscellaneous duties and projects as assigned and required.
As part of Top Management, you have the overall responsibility and accountability for all aspects of the Health, Safety, Environment, Energy, and Quality Management Systems, including the following:
taking overall responsibility and accountability for the prevention of work-related injuries and ill health, the protection of the environment, as well as the provision of safe, harmless, and healthy workplaces,
ensuring that the Health, Safety, Environment, Energy, and Quality Management Systems' policies and related objectives are established and are compatible with the strategic direction of the organization
Salary Range: $190,000 - $225,000
• Position is eligible to participate in a bonus plan with a target of 16% of the base salary
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
POSITION REQUIREMENTS
Bachelors of Science degree in related field or equivalent education and experience.
10 years of experience in pharmaceutical manufacturing in a cGMP environment required with 5 years of progressive levels of managerial experience and broad span of organizational control.
Terminal sterilization and lyophilization experience preferred.
Excellent analytical and technical skills.
Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment to meet plant and company objectives.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyMicrobiology Overnight Associate Scientist
Melrose Park, IL job
Responsible for collection and testing of routine environmental monitoring samples within aseptic processing fill lines, Isolator fill line, compounding, sterility suite, and component preparation areas for aseptic lines (Building A) and clean rooms areas in new expansion Building B. Collect and test utility samples such as WFI, clean steam and compressed gases. Monitors environmental conditions in laboratory areas during test sessions. Reports testing results and documents in compliance with cGMP and GLP standards. Provides support to Scientist, Lead Scientist, and Supervisor. Prepares media, reagents, sanitizing solutions and equipment for use in testing.
Salary Range: $26.00-$28.00 per hour.
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities
Perform environmental monitoring in controlled areas for non-viable airborne particulate, viable airborne bioburden, viable surface bioburden, settle plate bioburden and personnel monitoring.
Maintain gowning certification and apply good aseptic technique and clean room behavior.
Collect and process samples for water for Injection (WFI), clean steam and compressed gases according to established standard operating procedures.
Perform bioburden, endotoxin, Total Organic Carbon (TOC), and conductivity testing for utility samples.
Perform sub-culturing and Gram-staining of microorganisms.
Perform growth promotion on incoming media to release for monitoring use in the facility.
Maintain and review temperature records, lab cleaning records, and logbooks.
Input results in Laboratory Information Management System (LIMS) database and track microbiological results. Must be able to understand and follow company's good documentation practices.
Compile and submit environmental monitoring data for critical system release.
Supports Scientist/ Lead Scientist/ Supervisor with testing and special projects. Carries out special projects independently as required and assigned by supervision.
Aids with plant and laboratory equipment re-qualifications as directed.
Promptly reports data discrepancies and out of limit conditions to supervision. Carries out documentation, and assist Scientist and Lead Scientist with investigation, incident reports and corrective actions as assigned.
Assists in training new departmental personnel in standard operating procedures, training modules and checklists.
Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department.
Maintains compliance with company policies, training requirements, cGMP's.
Follow safety requirements, maintains good housekeeping of lab areas including 5S
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyMaintenance Tech 1
Lombard, IL job
Description As a Maintenance Technician, you'll ensure our filling lines for dishes, bottles, and tubes, packaging equipment, mobile sterilizers, and autoclaves operate safely and efficiently. You'll troubleshoot production-line issues, perform preventive maintenance, and rigorously apply lockout/tagout procedures. Things you will do will include diagnosing and resolving mechanical, electrical, pneumatic, and hydraulic issues on filling and packaging lines. Also you will be performing routine inspections and preventive maintenance on conveyor systems, pumps, motors, mobile sterilizers, and autoclaves. Lastly, you will partner with production operators to investigate root-cause failures and reduce unplanned downtime. Position Responsibilities:
Perform maintenance and repair tasks on manufacturing equipment, ensuring compliance with safety and quality procedures.
Collaborate with team members to resolve technical issues and escalate complex problems to senior technicians and supervisors as needed.
Document maintenance work and report on performance, including conducting inventory checks and managing spare parts availability.
Participate in training and development programs
Analyze basic maintenance data to drive continuous improvement and contribute in logistics and administrative management of maintenance activities.
Minimum Requirements:
High School Diploma, GED or equivalent
1+ years of applicable experience in Maintenance Tech
Knowledge, Skills, and Abilities
Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
Make timely decisions by quickly choosing effective solutions in high-pressure situations for optimal outcomes
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
Organizing work and resources efficiently to ensure smooth operations
Troubleshooting issues to identify and resolve problems efficiently
Collect and analyze data to drive informed decision-making to improve performance and identify issues
Effective Presentation Skills - including the ability to present technical data
Effective verbal communication skills
Maintain composure by having the skill of staying calm, focused, and professional in high-pressure or stressful situations.
Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.
Working Conditions and Physical Requirements
Ability to remain in stationary position, often standing, for prolonged periods.
Ability to ascend/descend stairs, ladders, ramps, and the like.
Ability to wear PPE correctly most of the day, including gloves, hairnet, clean room gowns and/or lab coats, safety glasses and hearing protection.
Ability to adjust or move objects up to 50 pounds in all directions, with repetitive hand and arm motions, and moving containers of cartons, tubes, and materials
The estimated salary range for this role based in Illinois is between $28.00 - $40.48. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer. In addition, bioMérieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site ******************************* or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux's or its affiliates' application process by contacting us via telephone at **************, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
Auto-ApplySenior Scientist, Formulation Development
Melrose Park, IL job
The Senior Scientist is responsible for conducting development studies with increasing complexity in nature and solving problems to ensure a stable product can be manufactured in the production facility. * This position requires working onsite at our Innovation and Development Center in Melrose Park, IL.
* This position is not eligible for sponsorship either now or in the future.
* Salary Range: $85,000-100,000
* Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.
* Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
* Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Responsibilities
* Accepts responsibility for all stages of product development including on-site monitoring of stability lot manufacturing.
* Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.
* Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems.
* Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements.
* Scales up the manufacturing process and transfers the technology accurately to the production plant.
* Sets product specifications based on stability results and according to FDA and ICH guidelines.
* Writes Chemistry, Manufacturing and Control (CMC) section for Regulatory submission.
* Responsible for product and process improvement as well as for ideas for new products, line-extent, product stability improvement and novel drug delivery systems.
* Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
Job Requirements:
* Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5+ years of related experience; or a Master's Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 3 years of related experience; or a PhD in Pharmaceutical Sciences, Chemistry, Biological Sciences, Chemical/Biomedical Engineering with 0-3 years of related experience is required.
* Must possess skills of designing and executing experiments using different lab instruments and techniques.
* Must have knowledge of statistic and analysis/interpretation, and pharmaceutical dosage forms. Experience in developing novel drug delivery systems is a plus.
* Must be willing to perform drug product development for potent compounds, cytotoxic substances and/or controlled substances while following and observing all safety procedures in place, which include the use of engineering controls, administrative controls, Standard Operating Procedures (SOPs), training, and Personal Protective Equipment (PPE).
* Must be willing to travel domestically and internationally to production plant to support batch manufacturing, etc.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyAssociate II, Regulatory Affairs
Lake Forest, IL job
Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables. With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.
Essential Duties & Responsibilities
Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
With oversight, understand and respond to regulatory agency correspondence.
Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.
Knowledge & Skills
Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
Prepare and maintain regulatory strategy with supervision.
Exercise good judgment within policy and regulations.
Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management.
Presents scientific data effectively orally and in writing in a logical and persuasive manner.
Provides daily regulatory support to new product development teams and commercial support with guidance.
Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
Acts with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management.
Minimum Qualifications, Education & Experience
Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
RAC Certification preferred
A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
Able to assess scientific arguments and apply analytical and logical reasonings.
Ability to effectively prioritize workload and multitask with minimal supervision.
Good interpersonal skills.
Good oral and written communications skills.
Demonstrated project management skills.
Demonstrated critical thinking, contingency planning and negotiating skills.
Understanding of regulatory and business needs with ability to engage cross functional team members.
Must be at least 18 years of age
Work Environment
This is largely a sedentary role.
This job routinely uses standard office equipment.
Typically requires travel less than 5% of the time.
Salary Range - $63,750 - $91,375
The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
ICU Medical provides a comprehensive total rewards package that includes:
Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
A wide range of benefit options at affordable rates
Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
Additional information on health and welfare benefit offerings can be found at ******************************************************************
Auto-ApplyInspector I
Melrose Park, IL job
Job SummaryResponsible for visually inspecting filled product off the filling line following Standard Operating Procedures Dept. and on the off-line inspection area and therefore must be knowledgeable of procedures and (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping equipment in each area
Pay Range: $19.91 - $21.66Responsibilities
The Specialist performs some or all of the following accountabilities as assigned:
· Visually inspects products for various defects.
· Documents work accurately and timely.
· Complies with current SOP's and cGMP's.
· Sets-up, adjusts, and operates equipment such as inspection machines, cappers, etc.
· Performs and documents critical start-up procedures for filling operation such as filter integrity test, line clearance, component verification, etc
· Performs and documents quality checks on product.
· Calculates percent defective on inspection results and reconciles components on batch record.
· Loads and unloads vials from turntables. Stacks, wraps and moves pallets of product. Performs other duties as assigned.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyPrincipal Human Factors Engineer
Round Lake, IL job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your role at Baxter
Apply human factors engineering principles to compose, develop, and evaluate medical products while working with cross-functional project teams. With minimal mentorship, plan, schedule, and lead human factors engineering activities for innovating new and improving existing medical products with product collaborators (customers, marketing, and engineering).
What you'll do
* Develop and communicate project scope, plans, tasks and deliverables with program teams and manage time to meet project deadlines. This includes reporting pertinent information at key achievements through clear, concise oral and written communications.
* In partnership with other R&D teams, develop product prototypes for user interface evaluation and validation.
* Perform human factors/usability studies (formative and summative) for hardware, software, labeling, and disposable products.
* Present and advise on human factors topics across the organization.
* Without appreciable direction, responsible for directing and coordinating all human factors activities necessary to complete a major product development program or several small projects.
* Lead efforts to develop processes and procedures that align to Baxter initiatives and FDA/international human factors standards.
* Provide technical supervision to less experienced human factors engineers, and may be responsible for the management of a small work group.
* Participate in continuous learning initiatives to expand expertise in human factors engineering and enhance skills in emerging areas of user experience creation to boost personal efficiency.
What you'll bring
* Bachelor's in Human Factors Engineering (HFE), or a related field (such as Industrial Engineering, Biomechanical Engineering, Human-Computer Interface, Applied Psychology, etc.); Master's or PhD is desirable;
* At least 5 years of practical experience in human factors is required.
* Demonstrated expertise in HFE principles and methodologies (including ergonomics, human computer/machine interface, data collection, data analysis, etc.).
* Demonstrated expertise in implementing human factors methodologies throughout projects spanning the product lifecycle (including user research, prototyping, formative and summative product assessments, analysis of use-related risks, etc.).
* Demonstrated track record in successfully applying HFE requirements/standards.
* Effective interpersonal abilities in both written and verbal communication.
* Shown capability to form conclusions and provide suggestions derived from technical inputs across various functions such as Marketing, Quality, Regulatory, etc.
* Demonstrated understanding of user centered development, heuristic evaluations, invention of experiments, and qualitative data analysis.
* Displayed capability in delivering technical leadership for HFE projects with considerable complexity and scope.
* Ability to solve HFE problems with minimal assistance.
* Ability to decompose complex problems into actionable task lists.
* Understanding of development requirements for composing, validating, and verifying medical products.
* Experience with operating in a regulated environment (e.g., FDA) with comprehension of implications for medical device and healthcare applications.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000-$143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
#li-tv1
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Marketing Manager - Segment Marketing
Chicago, IL job
*The ideal candidate for this role will be based in Chicago, but candidates residing in other biotech prominent markets will be considered.
The Marketing Manager for Segment & Solution Marketing is responsible for executing targeted marketing strategies to drive business growth for our Pharmaceutical Quality Control (PQC) franchise in North America. This role involves collaborating with cross-functional teams to develop and implement marketing plans that effectively position our solutions, support product launches, and enhance brand visibility across key segments. The Marketing Manager will focus on downstream (segment marketing) and upstream (solution marketing) strategies, ensuring alignment with overall business objectives and product availability.
Primary Duties
Segment Marketing Strategy & Execution:
Develop and implement marketing in the form of a marketing plan tailored to specific customer segments within the PQC franchise.
Analyze market trends, customer needs, and competitor activities to identify key growth opportunities.
Develop targeted messaging and positioning for PQC solutions in alignment with segment needs.
Collaborate with the Sales team to create segment-specific sales tools, collateral, and presentations.
Contribute, with Global teams, to characterize innovation needed for the NORAM market”.
Support the value selling efforts made by the commercial team in this segment
Solution Marketing & Product Launches:
Collaborate with Product Management to define product positioning, messaging, and go-to-market strategies for new and existing solutions.
Develop marketing materials, including product brochures, case studies, and technical content, to support solution marketing efforts.
Partner with the Sales team to execute product launch plans, including training materials, webinars, and promotional campaigns.
Collaborate with Supply chain and sales administrators/sales managers to review forecasts of current and new products to ensure product availability and alignment with market demand in North America.
Work closely with Global Solution Marketing teams to adapt global strategies for the North American market, ensuring consistency in messaging and readiness for customer delivery.
Content Development & Campaign Management:
Develop compelling content for marketing communications, including digital and print collateral, social media posts, blog articles, and case studies. This will be done in collaboration with global communication and marketing.
Implement integrated marketing campaigns to drive awareness, lead generation, and customer engagement.
Track and analyze campaign performance, adjusting strategies to optimize ROI.
Market Research & Competitive Analysis:
Conduct market research to assess customer needs, industry trends, and competitive positioning.
Utilize data-driven insights to refine marketing strategies and recommend new initiatives.
Monitor the competitive landscape to identify emerging trends and potential threats.
Brand Management & Messaging:
Ensure consistent messaging and brand alignment across all marketing communications.
Support the implementation of brand guidelines in marketing materials and campaigns.
Coordinate with external agencies for content creation and graphic design as needed.
Cross-Functional Collaboration:
Work closely with Sales, other local Marketing professionals, Global Marketing and othe GlobalIndustry teams, Customer Service, and Supply Chain to align marketing efforts with business objectives.
Partner with Global Solution Marketing teams to provide North American market insights and align product availability with customer demand.
Collaborate with Supply Chain teams to address potential gaps in product availability and communicate proactively with stakeholders.
Budget & Performance Monitoring:
Assist in managing the marketing budget for assigned segments and solutions.
Track and report on campaign performance metrics, identifying opportunities for optimization.
Provide regular updates on marketing initiatives and outcomes to senior leadership.
Qualifications & Requirements:
Bachelor's degree in Health Care related sciences or technological Marketing, or a related field; MBA a very nice to have.
5+ years of experience in marketing, preferably in life sciences, healthcare, or B2B sectors.
Demonstrated experience in segment marketing, product marketing, or solution marketing.
Strong written and verbal communication skills, with the ability to create compelling marketing content.
Proficiency in digital marketing tools, CRM systems, and data analysis.
Excellent organizational skills, with the ability to manage multiple projects simultaneously.
Experience working in a matrix organization and collaborating with global and regional teams.
Proven ability to manage product availability and coordinate with Supply Chain and Global Marketing to align marketing plans with operational capabilities.
Willingness to travel (up to 20%) to support field activities, product launches, and industry events.
The estimated salary range for this role based in Illinois is between $114,100 - $142,100. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.In addition, bioMérieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site ******************************* or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux's or its affiliates' application process by contacting us via telephone at **************, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
Auto-ApplyAutomation Engineer
Lombard, IL job
Description The Digital Manufacturing Systems Engineer plays a key role in the site's digital transformation by designing, developing, and deploying electronic manufacturing records and digital workflows. This role leads integration between manufacturing systems (e.g., Tulip MES, Blue Mountain RAM, LabVantage LIMS) and equipment networks, enabling real-time data capture and compliance. The engineer will also support light PLC/HMI programming to facilitate machine-level connectivity. This cross-functional role bridges operations, quality, IT, and engineering to create smart, efficient, and compliant production systems. Main Duties: Automation Systems Management:
Develop and maintain programmable logic controllers (PLCs), human-machine interfaces (HMIs), SCADA systems, and other manufacturing automation equipment.
Conduct routine inspections and preventive maintenance to ensure maximum system uptime and reliability.
Troubleshoot and resolve issues promptly, implementing long-term solutions that improve system robustness.
LIMS (LabVantage) Administration:
Serve as the site-level SME and administrator for the LabVantage LIMS platform.
Configure and optimize sample management workflows, user roles, templates, and reporting tools.
Support Quality and Laboratory teams in managing LIMS-related operations, investigations, and data integrity requirements.
Integrate LIMS with other systems (MES, ERP, instruments) using scripting and standard protocols (e.g., JavaScript, SQL, XML).
Coordinate with global IT and vendor support for upgrades, issue resolution, and enhancements.
Manufacturing Execution Systems (Tulip):
Develop and configure Tulip-based MES applications, including workflows, dashboards, and digital forms.
Support UI/UX design to enhance usability for operations teams.
Maintain system integrity through routine updates, backups, and performance monitoring.
Lead integrations between MES and other site systems (e.g., ERP, LIMS) using APIs or middleware.
Project Implementation and Coordination:
Lead small to mid-sized projects related to system implementation, integration, or upgrade.
Collaborate with cross-functional teams and external vendors to execute projects on time and within budget.
Participate in commissioning, qualification, and validation activities.
Compliance and Quality Assurance:
Ensure digital systems meet regulatory standards, internal procedures, and GMP expectations.
Support audit readiness and documentation related to electronic systems and data.
Maintain up-to-date SOPs and validation protocols.
Continuous Improvement:
Identify and implement improvements in digital workflows to enhance efficiency and reduce manual work.
Stay informed on digital manufacturing trends and propose new technologies.
Analyze performance metrics and suggest system enhancements to better support operational goals.
Minimum Qualifications:
Associate's degree in Electrical Engineering, Automation Technology, Industrial Technology, Mechatronics, or related technical field. Or Technical Certificate required.
Bachelor's degree in Engineering (Electrical, Mechanical, Industrial, Automation) or related technical discipline. Preferred
5+ years of relevant professional experience in an automation engineering, controls technician, or equivalent technical role Preferred.
Experience in regulated manufacturing environments (e.g., pharmaceuticals, medical devices, biotechnology, food and beverage industries). Preferred
Knowledge, Skills and Abilities:
Technical Skills:
Proficiency in PLC programming languages (e.g., Allen-Bradley, Siemens, Rockwell Automation).
Experience configuring and managing SCADA and HMI systems.
Working knowledge of manufacturing execution systems (MES) and relevant software solutions.
Familiarity with electrical controls, instrumentation, and mechanical systems.
Understanding of industrial networking and data integration principles.
Soft Skills & Behavioral Competencies:
Strong analytical, critical thinking, and problem-solving skills.
Excellent organizational and time-management abilities.
Exceptional communication and interpersonal skills to effectively collaborate with team members and stakeholders at various levels.
Adaptability and flexibility in dynamic environments, proactively addressing challenges and managing changing priorities.
Commitment to continuous professional development and learning new technologies.
The estimated salary range for this role based in Illinois is between $87,600- 115,200. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer. In addition, bioMérieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves
#biojobs
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site ******************************* or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux's or its affiliates' application process by contacting us via telephone at **************, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
Auto-ApplySenior Sourcing Specialist
Lake Zurich, IL job
Job SummaryThe Senior Sourcing Specialist is responsible to perform and steer tactical sourcing initiatives within defined thresholds and in accordance with relevant category strategies within a country. This covers demand clarification, performing of sourcing initiatives incl. tendering, negotiation, awarding, supplier relationship management and managing the purchase order processing for the related sourcing initiatives.
*This position requires working on-site at our Lake Zurich, IL site 3 days per week; the other days may be worked remotely.
*This position does not offer visa sponsorship either now or in the future.
• Salary Range: $85,000-100,000
• Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities
Ensure achievement of defined objectives and KPIs, including delivery of savings targets
Report and analyze the status of sourcing activities, plan-to-strategy
Support and implement category strategy development: provide local requirements and data, actively participate in category working groups, align with local stakeholders Implement category strategies within country source-to-contract
Clarify sourcing request, align and finalize specification with requestor, review if sourcing is required in alignment with category sourcing strategy
Define and implement sourcing strategy / RFX approach
Manage supplier selection decision making and supplier awarding
Manage contract creation and review process with internal functions and supplier
Manage sign-off and archiving of contract
Monitor contract usage, expiration / renewal
Support commercial aspects of e-catalog management Supplier Relationship Management
Manage supplier registration and pre-qualification of country specific suppliers
Evaluate and provide feedback on supplier performance (hard and soft facts)
Manage supplier performance, create development plans, define and track improvement measures
Conduct supplier disqualification and phase-out
Job Requirements:
Bachelor's degree preferred in Business Management or Engineering
5+ years of procurement experience
Proficient understanding of the end-to-end procurement process (plan-to-strategy, source-to-contract, purchase-to-pay)
Proficient user in MS Office (MS Word, MS Excel, MS PPT)
Proficient user in SAP ERP (SAP MM, SAP SRM, SAP FI)
Optional: Basic user in Sourcing Tool e.g., SAP Ariba Sourcing, Supplier Management
Professional negotiation skills
Manage supplier relationships including supplier escalations
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyManufacturing Supervisor - 3rd Shift
Round Lake, IL job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your role at Baxter
3rd Shift: 11pm-7:30am
You will be responsible for implementing and supervising daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. May monitor and control labor.
Your team
Baxter is focused on saving and sustaining lives by finding solutions to sophisticated problems. Every single day, the manufacturing team strives to create quality products for our customers-and are sometimes met with unforeseen issues to tackle. The high-caliber talent at Baxter meets these challenges head-on, as a team, to create products with the customer's needs top-of-mind.
We build relationships with each other to get work done.
We provide opportunities for you to continue to learn through training, conferences, certifications, and support for advanced degrees. Growth from role to role or level to level is encouraged and is supported by management to ensure employees are consistently engaged with their work.
What you'll be doing
* Will provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
* Responsible for supervising the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities -to meet customer requirements including deadlines and quality standards.
* Audit, refine, and improve processes and equipment operation within the manufacturing areas. Drive to utilize resources and raw materials in the most efficient and productive manner possible.
* Support and Emphasize the Safety and Quality commitments of the department.
* Interview, hire, coach, motivate, develop and discipline staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Monitor progress.
* Facilitate and verify appropriate training for employees in the area.
* Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
* Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.
* Represent the Company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
* Provide a positive and equitable working environment emphasizing the Baxter.
* Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed.
Candidate should not be allergic to PENICILLIN or CEPHALOSPORINS
What you'll bring
* HS diploma or equivalent required and 2 years manufacturing and 1 year of leadership experience.
* Bachelor's degree and 1 year of experience.
* Bachelor's degree required for ongoing career progression
* Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment
* In-depth process knowledge of related manufacturing equipment and processes.
* good understanding and/or hands-on familiarity with the principles of lean manufacturing.
* Ability to manage multiple priorities in a manufacturing plant setting.
* Ability to interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel issues. Strong assessment and troubleshooting skills.
* Collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions
* Strong professional writing skills and ability to prepare technical reports.
* Ability to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
* Ability to respond to detailed inquiries, and present information to groups and senior management.
* May be required to supervise multiple groups.
* Ability to work weekends and overtime when necessary is required.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $64,000 - $88,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Sr. Manager, Electrical Engineering
Round Lake, IL job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your Role at Baxter
We are seeking a hands-on, technically rigorous, and people-centered engineering leader to serve as Sr. Electrical Engineering Manager for infusion systems. This role has full responsibility for both new product development (NPD) and sustaining engineering of embedded electronics, sensor interfaces, power systems, GUI display hardware, and safety-critical control systems. You will lead a team of electrical engineers and partner closely with embedded software, mechanical, systems, manufacturing, and quality functions to deliver safe, high-performing, and compliant medical devices for fluid delivery.
This role is based out of the Round Lake, IL location. Relocation Assistance available.
What You Will be Doing
Technical Ownership
* Lead the design, development, and support of embedded electronic systems across the entire product lifecycle, including:
* Microcontroller-based control platforms.
* Sensor integration (e.g., pressure, flow, air-in-line, occlusion).
* Motor and actuator drive electronics.
* Power architecture (AC/DC conversion, battery backup, energy optimization).
* GUI display electronics: Display controllers, backlight drivers, capacitive touch hardware, and power regulation.
* Architect robust, EMI-compliant hardware interfaces that support GUI responsiveness, user interaction, and system-level diagnostics.
* Ensure all designs meet regulatory and quality standards, including IEC 60601-1, 60601-1-2, 60601-2-24, FDA design control, and ISO 13485.
* Define and maintain hardware/software interface requirements in collaboration with embedded software teams; own the electrical side of the integration.
* Lead design documentation, schematic reviews, FMEA, hazard analysis, and verification test planning for both new and existing products.
Leadership & Team Management
* Hire, mentor, and develop a high-performing team of electrical engineers focused on embedded control, analog/digital design, GUI electronics, and power systems.
* Drive the team across both development projects and sustaining activities, including CAPAs, field investigations, root cause analysis, and design updates.
* Drive a culture of engineering excellence, ownership, and continuous improvement, balancing risk management and innovation.
* Set technical direction, manage work prioritization, and ensure high-quality deliverables in alignment with program and business goals.
* Embedded software teams on firmware integration, diagnostics, controls, and alarm management.
* GUI software teams to ensure compatibility and performance of user-facing display hardware.
* Mechanical teams for PCB layout, connector integration, thermals, and enclosure constraints.
* Represent the electrical function in program reviews, design phase gates, and regulatory audits.
What You'll Bring
* Bachelor's or Master's degree in Electrical Engineering or closely related field.
* 10+ years of embedded electronic design experience in regulated, safety-critical environments (medical preferred).
* 5+ years of technical people leadership experience, with direct responsibility for both new product development and sustaining support.
* Proven success in delivering reliable, compliant, and manufacturable electrical subsystems from concept through post-market support.
* Strong cross-functional communication skills and the ability to lead in a matrixed, global development environment.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $144,000 - $198,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. #LI-ASR2
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Scientist I
Melrose Park, IL job
Job SummaryA Scientist I in Quality Control Microbiology is responsible for an intermediate level of expertise of microbiological test methods, and instrumentation. A Scientist I participate in the mentoring and training of less experienced analysts in the group. The QC Microbiology department contains five main functional groups. The principal activities vary slightly between the groups.
Hourly Range: $28.00-$32.00
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage Responsibilities
Schedules, initiates, coordinates, performs routine and non-routine environmental monitoring according to established procedures. Must be organized to coordinate activities of multiple filling rooms and associated personnel and do independently.
Assess environmental conditions using various methods to sample environment, water systems, compressed gas, and personnel in production areas and microbiology laboratory. Recognize out of limit results and initiate OOL investigations.
Must successfully execute requirements to achieve ISO Class 5 gowning certification.
Processes paperwork, LIMS input and approvals for release by QA Critical Systems.
Solid working knowledge of KabiTrack and recording OOL events and change controls. Assists with investigation of environmental OOL excursions.
Coordinate responses and actions associated with environmental issues.
Maintain good housekeeping of laboratory areas, environmental chambers and maintain inventory of test media, reagents as assigned.
Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification.
Assists in training manufacturing personnel in required aseptic techniques, and gowning techniques as assigned by supervisor.
Responsible for coordinating the timely completion of routine testing.
Processes and completes data collection for all critical systems release.
Process data and recognize issues and be instrumental in escalating associated results with unexpected results or trending.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyFinancial Analyst Intern
Deerfield, IL job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your Role at Baxter
The Financial Analyst Intern position provides aspiring, financially oriented business students a range of outstanding experiences in corporate accounting and finance. In this role, whether you are tracking critical performance metrics, collaborating cross-functionally with other teams, or forecasting the future landscape of the business, our leaders will use your work to drive the strategic decisions of the company. While you'll be expected to have a keen attention to detail in month-end reporting and ad-hoc modeling, you'll also be challenged to think creatively to improve processes and handle big picture projects. Additionally, you'll receive structured training and guided mentorship from appointed teammates.
What You'll Be Doing:
* Analysis of monthly and quarterly financial results and business drivers; preparation of critical financial reporting
* Ownership of budgeting, forecasting, and long-range planning processes
* Enablement of internal decision-making and investment prioritization via financial models and analytics
* Responsible for reconciliation of balance sheet accounts, preparation of month-end close journal entries, and review of account trending
* Contribution to ad hoc projects and specialized team functions
What You'll Bring:
* Actively pursuing a bachelor's or master's degree in Finance/Accounting or related field of study. Minimum GPA of 3.0 required
* Excellent communication and interpersonal skills
* Ability to adapt quickly in a complex, team-oriented environment
* Detail and results oriented
* Analytical skills with ability to contribute to accounting processes, financial analysis, and reporting
* Robust technical proficiencies (e.g. Excel, PowerPoint), finance and accounting knowledge, and business acumen
* Capable of handling several projects/tasks at once
* Ability to work in a team-oriented environment.
* Detail Oriented.
* Technical and financial knowledge including, internal control requirements and accounting principles as well as understanding of relevant business environment.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $52,000 to $54,080 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Supv, Facility Maintenance
Round Lake, IL job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your role at Baxter:
The supervisor position is responsible for directing the daily activities of a maintenance team. These responsibilities as well as others could include setting priorities, assigning work, being a technical resource, personnel development and collaborating with others to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), good documentation practices (GDPs) environmental health and safety (EHS) guidelines and any other regulations that could apply.
Your Team:
At Baxter, we are passionate about saving and sustaining lives by finding solutions to sophisticated problems. Every single day, the manufacturing team strives to create quality products for our customers-and are sometimes met with unforeseen issues to tackle. The high-caliber talent at Baxter meets these challenges head-on, as a team, to create products with the customer's needs top-of-mind.
What you'll be doing:
* Supervise and lead a maintenance team that could include mechanics and technicians to support operations
* Be responsible for execution of assigned shutdown work and / or other projects.
* Support and Emphasize the Safety and Quality commitments of the department - make decisions concerning these commitments within the area.
* Identify/prioritize/provide resources on a shift to assist the Maintenance Manager to meet the annual operational plan and budgetary commitments,
* Facilitate, verify, and conduct appropriate training for employees in the area (including but not limited to GMP, troubleshooting, maintenance skills, and safety)
* Ensure compliance with all GMP rules, specifications, SOPs, and FDA requirements as the need arises.
* Contribute to employee feedback and developmental process - support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization, and complete monthly A.C.E. (Align, Check-in, and Execute) meetings with team members.
* Sustain a clean and safe work area using 6S principles
What you'll bring:
* Associates degree in scientific or engineering required, bachelors degree preferred.
* Minimum of 5 years of Industrial Maintenance experience / Manufacturing Supervision experience or equivalent.
* Candidate should not be allergic to PENICILLIN or the CEPHALOSPORINS
* Demonstrated communication, administrative and strong technical leadership skills with ability to interface well with other departments and lead optimally and efficiently in a team environment. Solid professional writing skills.
* Ability to manage multiple priorities in a manufacturing plant setting.
* Good assessment and troubleshooting skills (mechanical, electrical, and process) with demonstrated and proven experience and background.
* Solid understanding of maintenance systems to include preventive maintenance and CMMS.
* Ability to understand regulatory and safety guidelines applicable to the medical / pharmaceutical industry and industry in general. Experience and knowledge with Lockout/ Tagout and other Safety Programs is a plus.
* Knowledge of World Class Manufacturing methods (TPM, Right the first time, Quality Control).
* Ability to respond to detailed inquiries, and present information to groups and department management.
* Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
* Must have basic English written and oral communication skills adequate to communicate with other team members.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $80,000 - $110.000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are un-able to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Project Manager, Engineering
Melrose Park, IL job
The Engineering Project Manager leads and coordinates cross-functional projects to ensure delivery on time, within scope, and on budget. The role requires a balance of technical knowledge, structured project management, and leadership skills to plan, organize, and execute projects while maintaining clear communication with stakeholders.
Responsibilities
Project Management
Plan, structure, and execute projects from initiation to completion, ensuring timelines, resources, and deliverables are aligned.
Apply project management methodologies to ensure effective execution and risk management.
Define clear project goals, milestones, and timelines, and implement structure from the start.
Technical Leadership
Leverage knowledge of product properties (aseptic, TS, bags, syringes, etc.), manufacturing technologies, and pharma execution strategies.
Support design reviews, qualification activities, and technical decision-making.
Drive structured problem solving and simplify complex challenges into actionable steps.
Business & Financial Management
Oversee project budgets, ensure cost control, and deliver within approved financial parameters.
Monitor and report on project performance to stakeholders, including senior leadership.
Team Leadership & Collaboration
Motivate, guide, and align cross-functional teams while managing conflicts and facilitating decision-making.
Communicate clearly and transparently with all stakeholders, including internal teams, customers, and senior leadership teams (SLT).
Ensure every voice is heard and considered in the decision-making process.
Continuous Improvement
Encourage team self-reflection and learning, fostering a culture of continuous improvement.
Identify and implement process enhancements to improve efficiency and effectiveness.
Travel
Expecting 20-30% travel based on projects
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyValidation Engineer
Melrose Park, IL job
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.Responsibilities
Responsibilities:
Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs).
Coordinates and communicates all testing with affected functional groups and evaluates test results.
Assembles and composes the final report and circulates for approval
Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
Schedules and executes HEPA Filter and Critical Area (Class 100) testing per SOP. Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Requirements:
Bachelor's degree in a Science or Engineering field of study required
Minimum of one year relevant work experience in a cGMP regulated industry.
Experience generating reports, deviations or other technical documents.
Experience with Installation, Operational and Performance Qualification protocol generation and execution strongly preferred.
Analytical datalogger programming, operating, troubleshooting, data-collecting preferred.
PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
Knowledge of cGMP Cleaning Validation requirements and techniques
Knowledge of cGMP Process and Product Validation requirements and techniques.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-Apply