Full-Time
Overnight Maintenance Mechanic
Updated on 8/23/2026
Fresenius Kabi
10,001+ employees
Global provider of therapies and devices
Compensation Overview
$30 - $32/hr
Melrose Park, IL, USA
In Person
Bachelor's
 General Maintenance & Repair (1) |
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- A high school diploma or GED is required.
- At least 3 years of maintenance mechanic experience in a regulated, technical work environment is required.
- Ability to read, write, and perform mathematics at a level sufficient to complete technical work.
- Ability to apply principles and practices across skilled-trade areas including plumbing, programmable logic controllers, controls, robotics, boilers, heating, ventilation and air conditioning systems, mechanical, electrical, carpentry, and welding.
- Ability to stand or kneel for extended periods during repairs.
- Basic computer skills and technology aptitude, including the ability to work with Microsoft Office and SAP.
- Ability to climb ladders and lift up to 50 pounds as required.
- Ability to achieve aseptic gowning certification.
- Working knowledge of good manufacturing practices, lockout/tagout, and arc-flash safety.
- Ability to work overtime and weekends when required.
- Ability to effectively speak, read, write, and understand English to perform essential job functions.
- Perform preventative maintenance, operational functions, and repairs on assigned manufacturing equipment and systems in accordance with established safety practices and procedures.
- Provide emergency and unscheduled repairs of manufacturing equipment and systems during production and perform scheduled maintenance repairs during machine service as required by standard operating procedures.
- Perform mechanical, electrical, pneumatic, and hydraulic troubleshooting and repair of manufacturing machinery in a sterile, aseptic work environment while following proper gowning requirements.
- Comply with safety regulations and maintain clean and orderly work areas.
- Document all work performed in compliance with current good manufacturing practices standards.
- Detect faulty operations and defective material and report them, along with unusual situations, to proper supervision.
- Read and interpret blueprints, mechanical and electrical schematics, prints, and operating manuals to repair and maintain equipment.
- Perform general building maintenance as needed.
- Perform maintenance requiring knowledge of plumbing, pipefitting, carpentry, electrical, electronics, welding, and other skilled trades.
- Use hand and power tools, electric meters, and material-handling equipment while performing duties.
- Provide coverage for other mechanics within the scope of the employee's abilities, including daily readings, changing expendable items, and other tasks requested by leadership.
- Contribute ideas and suggestions for maintenance process improvements.
- Complete assigned training requirements.
- An apprenticeship or applicable certifications are highly preferred.
Fresenius Kabi provides medicines, medical devices, and related services to treat critically and chronically ill patients. Its portfolio includes biosimilars for autoimmune diseases and oncology, clinical nutrition products, infusion pumps and disposables, blood collection bags and devices, and IV fluids for infusion therapy. The company differentiates itself through leading positions in blood collection and infusion materials and by offering an integrated mix of pharma, nutrition, and MedTech under a single global platform. Its goal is to shape the future of healthcare by expanding leadership, improving patient care, and delivering sustainable value for stakeholders.
Company Size
10,001+
Company Stage
N/A
Total Funding
N/A
Headquarters
Bad Homburg, Germany
Founded
1999
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Simplify's Take
What believers are saying
- Q1 2026 Fresenius Kabi revenue reached €2.15 billion, with 5% constant-currency growth.
- August 2026 FDA approval of rituximab biosimilar adds near-term U.S. commercialization revenue.
- Vedolizumab review and TQ partnership position Kabi for higher-growth autoimmune and cell-therapy markets.
What critics are saying
- August 10, 2026 Tyenne recall exposed glass particles, threatening trust in sterile manufacturing quality.
- PB016 faces Takeda Entyvio and Alvotech AVT16 competition, compressing launch pricing and margins.
- Any repeated particulate, endotoxin, or CGT-device failure triggers FDA scrutiny and contract losses.
What makes Fresenius Kabi unique
- Fresenius Kabi combines biosimilars, MedTech, nutrition, and IV generics across 100+ countries.
- July 31, 2026 vedolizumab review and August 2026 rituximab approval widen its biosimilars pipeline.
- January 14, 2026 TQ Therapeutics deal embeds cell-selection technology into Cue Cell Processing System.
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Benefits
401(k) Retirement Plan
Health Insurance
Dental Insurance
Vision Insurance
Wellness Program
Remote Work Options
Hybrid Work Options
Paid Vacation
Paid Holidays
Paid Sick Leave
Family Planning Benefits
Fertility Treatment Support
Stock Options
Disability Insurance
Life Insurance
Professional Development Budget
Conference Attendance Budget
Phone/Internet Stipend
Home Office Stipend
Mental Health Support
Hospice?
Company News
Fresenius Kabi issues nationwide recall of Tyenne(R)(tocilizumab-aazg) Injection 400 mg/20 mL vials Due to Presence of Glass Particles. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Summary. * Company Announcement Date: - August 10, 2026 * FDA Publish Date: - August 11, 2026 * Product Type: - Drugs * Reason for Announcement: - Due to Presence of Glass Particles * Company Name: - Fresenius Kabi * Brand Name: - Fresenius Kabi * Product Description: - Tyenne Injection 400 mg/20 mL vial Company Announcement. August 10, 2026 - LAKE ZURICH, Ill. - Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne(R)(tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to contain glass particles. Risk Statement:The administration of an injectable product containing glass particulates may cause local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins. More seriously, glass particles can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Tyenne(R)(tocilizumab-aazg) Injection is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs); adult patients with giant cell arteritis; patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis; patients 2 years of age and older with active systemic juvenile idiopathic arthritis; adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome; and certain hospitalized adult patients with COVID-19. Recalled product can be identified as follows (with label below): | Product Name/Size | NDC Number | Product Code | Lot Number | Expiration Date | First Ship Date | Last Ship Date | | Tyenne(R)(tocilizumab-aazg) Injection, 400 mg / 20 mL (20mg/mL) 20 mL vial | 65219-594-20 | 590120 | 16UI07 | 08/2028 | 03/03/2026 | 03/25/2026 | Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL was distributed nationwide to wholesalers, distributors and direct customers. Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lot, they are to immediately discontinue distributing, dispensing, or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall. Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time or send an e-mail to either [email protected] or [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. * Complete and submit the report Online: www.fda.gov/medwatch/report.htm * Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Company contact information. * Media: - Matt Kuhn - (847) 220-3033
Fresenius Kabi advances global biosimilars portfolio with FDA, EMA review of vedolizumab candidate and U.S. Approval of rituximab biosimilar. Fresenius Kabi's vedolizumab biosimilar PB016 enters FDA and EMA review, while its rituximab biosimilar gains U.S. FDA approval, expanding access to biologics. Fresenius Kabi has achieved two important regulatory milestones within days, strengthening its global biosimilars portfolio across autoimmune diseases and oncology. The company announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory applications for review of PB016, its proposed intravenous (IV) vedolizumab biosimilar referencing Entyvio(R)(vedolizumab). Shortly thereafter, the FDA approved the company's rituximab biosimilar for the U.S. market, further expanding its biosimilar offerings in immunology and oncology. FDA and EMA Accept PB016 for Regulatory Review. The FDA accepted Fresenius Kabi's Biologics License Application (BLA), while the EMA validated the Marketing Authorisation Application (MAA) for PB016. The proposed biosimilar is being developed by Polpharma Biologics, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa, subject to regulatory approval. The regulatory submissions are supported by a comprehensive biosimilar development program designed to demonstrate that PB016 is highly similar to the reference product through analytical, non-clinical, pharmacokinetic, and clinical evaluations, consistent with global biosimilar approval requirements. Clinical program supports biosimilarity. The clinical evidence for PB016 includes a Phase 1 study in healthy volunteers and a Phase 3 clinical trial (NCT05771155) in patients with moderately to severely active ulcerative colitis. Together, these studies contribute to the totality of evidence required to establish biosimilarity to the reference biologic. Vedolizumab is a gut-selective monoclonal antibody that targets the α4β7 integrin, preventing inflammatory lymphocytes from migrating into gastrointestinal tissue. It is approved for adults with moderately to severely active ulcerative colitis and Crohn's disease, two chronic forms of inflammatory bowel disease (IBD) that affect an estimated 2.4 million people in the United States and approximately 2.5 to 3 million people across Europe. If approved, PB016 could expand treatment options and improve access to biologic therapy for patients living with IBD by providing a high-quality, lower-cost alternative to the reference product. FDA approves rituximab biosimilar for the U.S. Building on the momentum of the vedolizumab regulatory submissions, Fresenius Kabi also announced FDA approval of its rituximab biosimilar, developed by Dr. Reddy's Laboratories as a biosimilar to Rituxan(R)(rituximab). Under an exclusive commercialization agreement, Dr. Reddy's developed, manufactured, and submitted the product, while Fresenius Kabi holds exclusive U.S. commercialization rights. Rituximab is a CD20-directed monoclonal antibody indicated for multiple hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). The FDA approval was based on the totality of evidence demonstrating high similarity to the reference product, with no clinically meaningful differences in quality, safety, or efficacy. Strengthening the biosimilars portfolio. Together, the regulatory review of PB016 and the FDA approval of the rituximab biosimilar represent important advances in Fresenius Kabi's FutureFresenius strategy, which identifies biopharmaceuticals as a key growth area. The two milestones strengthen the company's presence in both autoimmune diseases and oncology while reinforcing its integrated capabilities across biosimilar development, manufacturing, and global commercialization. As biosimilars continue to improve patient access to biologic medicines, these regulatory achievements position Fresenius Kabi to further expand its global portfolio of high-quality, affordable treatment options for patients with chronic inflammatory diseases and cancer. Reference. About the writer. Kirti Kumbhar (LinkedIn) is an MPharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.
Fresenius Kabi and Polpharma submit aBLA for Proposed Entyvio(R)(vedolizumab) biosimilar PB016. On July 31, 2026, Fresenius Kabi and Polpharma announced the FDA acceptance of their aBLA for PB016 (vedolizumab), a proposed intravenous biosimilar of Takeda's Entyvio(R)(vedolizumab). They also announced the acceptance of their Marketing Authorisation Application (MAA) by the EMA for PB016. This is the second publicly announced aBLA for an Entyvio(R) biosimilar, following Alvotech's announcement of its aBLA for AVT16 in June 2026 (previously reported Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio(R) Biosimilar - AVT16). Currently, there are no pending patent disputes related to Entyvio(R) biosimilars, and no patents are listed in the Purple Book for Entyvio(R). Takeda reported FY2025 (Apr. 1, 2025 - Mar. 31, 2026) U.S. sales of JPY 623.7 billion (approximately $3.89 billion USD) for Entyvio(R). The author would like to thank April Breyer Menon for her contributions to this article.
Fresenius Announces FDA and EMA acceptance for review of Vedolizumab Biosimilar candidate. * U.S. FDA and EMA acceptance for review of Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, of intravenous vedolizumab biosimilar candidate, an integrin receptor antagonist. * Vedolizumab targets inflammatory bowel diseases, including moderately to severely active ulcerative colitis and Crohn's disease in adults. * Acceptance reinforces Fresenius Kabi's strategy to expand its autoimmune biosimilars portfolio and broaden patient access to biologic medicines. BAD HOMBURG, Germany-(BUSINESS WIRE)-#CommittedToLife-Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio(R)* (vedolizumab) lyophilized vial for intravenous (IV) administration. The applications were submitted by Polpharma Biologics S.A., with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals. "FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines," said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. "With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases." PB016, in-licensed from Polpharma Biologics S.A.[1], is a proposed biosimilar to IV vedolizumab, an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease in adults. Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe and continues to rise every year.[2,3] It is a chronic, progressive condition with no definitive cure and can have a significant, long-term impact on patients' quality of life. Once primarily associated with highly industrialized countries, IBD incidence continues to rise globally alongside increasing industrialization. In this context, biosimilars have the potential to expand access to effective biologic therapies. The submissions for the intravenous presentation are supported by a comprehensive development program evaluating the proposed biosimilar's similarity to the reference product, consistent with regulatory requirements for biosimilar approval. Biopharma is a core pillar of Fresenius' #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business, covering the entire value chain - from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high-quality, affordable biologic therapies. The FDA and EMA review acceptances represent the latest progression in Biopharma's growth strategy and strengthens its global biosimilars position. About vedolizumab Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut.[4] It is used in the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease in adults, chronic inflammatory diseases that can significantly impact patients' quality of life. Vedolizumab is administered by intravenous infusion. PB016 is being developed by Polpharma Biologics S.A., and Fresenius Kabi has exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approval. The biosimilar development program for vedolizumab is designed to demonstrate high similarity to the reference product through comprehensive analytical, non-clinical, and clinical studies, in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155).[5] About Fresenius Kabi Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company's broad portfolio enables access to high quality care across emergency medicine, surgery, oncology, intensive care, and at home - reaching 450 million patients each year. Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide. About Fresenius Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2025 fiscal year, Fresenius generated €22.6 billion in annual revenue. Fresenius currently counts over 178,000 employees. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in Fresenius Medical Care. With around 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 27 million patients every year. Fresenius Kabi's product portfolio touches the lives of 450 million patients annually and includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and intravenous generic drugs and fluids. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people's health. The largest shareholder is the non-profit Else Kröner Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects. References [1] Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar (2025). Available at: Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar [last accessed: June 2026] [2] Lewis J.D., Parlett L.E., Jonsson Funk M.L, et al. (2023) Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology, 165: 1197-1205. [3] Kumar A., Yassin N., Marley A. et al. (2024) Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic advances in Gastroenterology, 16, 1-16. [4] Wyant T., Fedyk E., Abhyankar B. (2016) An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. Journal of Crohn's and Colitis, 10(12), 1437-44. [5] ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio(R)(UCESIVE). Available at: Study Details | NCT05771155 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio(R) | ClinicalTrials.gov [last accessed: June 2026] * Entyvio(R) is a registered trademark of Millennium Pharmaceuticals, Inc., a Takeda company. Global Contact Information For more information, please contact: Fresenius Kabi Business Communications Email: [email protected]. July 31st, 2026 July 30th, 2026
Motility Treament Approved by FDA Motility Treament Approved by FDA Tuesday, December 18, 2018 (0 Comments) Posted by: Andrea Guidi Share | Facebook X Email LinkedIn New Treatment/Therapy Options New treatment/therapy options are available that may be helpful for some Oley members. If you think these might be helpful for you, mention them to your physician. Motility Treatment Approved (Motegrity(TM) The U.S. Food and Drug Administration (FDA) has approved Motegrity (prucalopride), a once-daily, oral treatment option for adults with chronic idiopathic constipation (CIC).According to the manufacturer, Shire PLC, "Motegrity, a selective serotonin-4 (5-HT[4]) receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility." Shire expects to launch Motegrity in the U.S. in 2019. The company explains, "While not all patients may be right for treatment, Motegrity represents an important new option." Click here to read Shire's press release. Pediatric Parenteral Nutrition Lipid Available (Omegaven(R) Fresenius Kabi has announced that Omegaven (fish oil triglycerides) injectable emulsion is now commercially available in the United States. Omegaven was approved by the FDA in July 2018. Previously the lipid had been available in the U.S. for compassionate use only. Omegaven is an intravenous lipid emulsion that provides calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis, or PNAC. The company says, "Omegaven is the first and only FDA-approved fish oil lipid emulsion for this condition." Click here to read Fresenius Kabi's press release. | " Back to Index | My Profile