Full-Time
Manufacturing Engineer
Posted on 7/7/2026
Fresenius Kabi
10,001+ employees
Global provider of therapies and devices
Compensation Overview
$80k - $95k/yr
Melrose Park, IL, USA
In Person
Bachelor's
 Mechanical Engineering (1) |
|---|
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- Bachelor’s degree in Engineering (Electrical, Automation, Controls, Computer, Mechanical, etc.).
- 1-3 years plant manufacturing experience.
- Understanding of control systems and PLC programming of highly automated manufacturing technologies (Siemens/Allen Bradley).
- Ability to coordinate and support contractors or team members as assigned.
- Excellent verbal and written communication skills (technical writing and presentation).
- Must be able to work independently and set priorities.
- Under general supervision, develops systems to identify and measure key performance indicators (uptime, downtime, scrap, yield).
- Consults with Sr Engineers and peers to identify key site capacity constraints and provide timely solutions to resolve.
- Uses Lean tools to measure, understand, and improve process variability and efficiency.
- With general guidance manages related capital projects adhering to budget and schedule constraints.
- Provides on-going technical support for manufacturing operations in aseptic filling.
- Analyzes daily production and processing problems, identifies and implement shop-floor continuous improvement projects.
- Establishes engineering tracking tools and enforce their usage through fact driven communication between all stakeholders (e.g., operations, maintenance, quality, engineering, technology center, suppliers, etc.).
- Coordinates maintenance and drive technical activities for cGMP compliant manufacturing improvement Works with production personnel to establish or revise work instructions and procedures used in the production environment.
- Ensures timely completion of the tasks and support as assigned by management.
- Maintains awareness of current pharmaceutical manufacturing needs and standards and communicates possible programs/projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site.
- Coordinates activities of various vendors for projects to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations.
- Prepares URS, Risk Assessments, Safety Assessments associated with the support of and execution of projects.
- Prepares specifications for projects to include all dimensions, electrical, HVAC and mechanical considerations.
- Works effectively with Operations and Quality to ensure project results are compliant with site and industry regulations and guidelines.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related
- Working knowledge of AutoCAD or SolidWorks 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
- July 31, 2026 FDA and EMA accepted PB016, advancing a high-value IBD franchise.
- Conexxence and Bomyntra reached eight percent EU5 biosimilar share by May 2026.
- FDA approval of rituximab biosimilar broadens oncology revenue beyond denosumab and tocilizumab.
What critics are saying
- August 2026 Tyenne glass-particle recall exposes manufacturing control failures after prior famotidine endotoxin recalls.
- PB016 faces Takeda Entyvio competition and Alvotech's June 2026 rival filing.
- Quality problems in injectables and pumps threaten trust, contracts, and future FDA scrutiny.
What makes Fresenius Kabi unique
- Fresenius Kabi controls biosimilar development, manufacturing, and commercialization across multiple regions.
- Its 2026 TQ Therapeutics deal extends Cue system capabilities into cell therapy manufacturing.
- Denosumab launches and PB016 expansion show breadth across osteoporosis, oncology, and immunology.
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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 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
Fresenius Kabi, TQ Therapeutics announce cell therapy technology agreement. Initiative Focused on Scaling Advanced Cell and Gene Therapy to Enhance Patient Access LAKE ZURICH, Ill., January 14, 2026 - Fresenius Kabi, an operating company of Fresenius, and TQ Therapeutics, announced today they have entered into a strategic-development agreement under which Fresenius Kabi has an exclusive license to develop, manufacture, and distribute products that incorporate TQ Therapeutics' proprietary cell selection technology. The goal of the agreement is to advance cell and gene therapy accessibility by enabling scalable and efficient cell therapy manufacturing. Fresenius Kabi is a leading provider of essential medicines and medical technologies. TQ Therapeutics specializes in proprietary cell selection technology and following therapeutic applications. Under the agreement, TQ Therapeutics' affinity and column-based cell isolation technology will be integrated into Fresenius Kabi's Cue(R) Cell Processing System. By combining these technologies, the companies aim to create an automated and robust system that can isolate T cells from whole blood and apheresis products in less than two hours for cell and gene therapy manufacturing applications. The goal is to quickly, easily and consistently produce high purity T cells, helping therapeutic developers work more efficiently and potentially bring treatments to patients faster. "With this collaboration, we are reinforcing our commitment to innovation in cell and gene therapy technology," said Saurabh Bhasin, Head of Portfolio, Cell Therapies & Contract Manufacturing Operations at Fresenius Kabi. "By integrating TQ Therapeutics' novel selection technology into our Cue system, our aim is to improve manufacturing success and scalability - key steps toward supporting the advancement of cell and gene therapies." TQ Therapeutics' goal is to leverage the Cue system and its integrated cell selection column technology to develop extracorporeal, ultra-short cell and gene therapy processes for clinical applications creating faster steps that can be performed closer to the point of care to help simplify and accelerate treatment workflows. "This agreement with Fresenius Kabi allows us to bring our proprietary technology to a broader audience with the goal of accelerating the development of next-generation cell therapies," said Christian Eckert, chief executive officer of TQ Therapeutics. "With Fresenius Kabi's expertise in cell and gene therapy device technologies development and commercialization, and TQ Therapeutics' focus on developing ultra-short processes for clinical cell therapies from manufacturing to in vivo applications, we are creating a novel value proposition for scaling and enabling the supply of cell therapies for broader patient populations." Cell and gene therapy is an emerging segment of medicine that has shown promise in treating certain cancers and other conditions. Phacilitate Advanced Therapies Week 2026 Fresenius Kabi and TQ Therapeutics will debut the Cue Cell Processing System and the in-development cell selection module at Booth #623 on February 10-12 during Phacilitate ATW 2026 in San Diego, CA. Attendees are invited to visit the booth to learn more about the technology and its development. About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company's products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company's I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication - making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders - shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. About TQ Therapeutics TQ Therapeutics GmbH (Martinsried, Germany) is a biotechnology company dedicated to advancing the field of cellular therapies through innovative technologies. The company's mission is to advance their transformative and modular CELLfinity platform, enabling advanced and affordable treatments in CGT. The platform is based on TQx's proprietary EXiVO approach - a hybrid extracorporeal in-vivo CGT. This technology will enable a new generation of autologous mRNA-T-cell therapeutics that deliver highly individualized cell therapies directly to the patient. This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.