Facilities Maintenance and Reliability Engineer
About the job
- A bachelor's degree in engineering, facilities management, or a related technical discipline with at least 2 years of relevant experience, or an associate degree/technical certification with at least 3 years of relevant experience.
- Experience supporting facility systems, utilities, maintenance, reliability, or engineering activities in a manufacturing environment.
- Working knowledge of current Good Manufacturing Practice, qualification, change control, deviation, corrective and preventive action, and Good Documentation Practice requirements.
- Demonstrated ability to troubleshoot technical issues, coordinate vendors, and manage assigned projects or workstreams.
- Ability to work on-site and provide support outside normal working hours when required.
- Independently troubleshoot and resolve facility equipment, utility, mechanical, electrical, heating, ventilation, air conditioning, and building system issues within the scope of training and qualification.
- Perform or coordinate preventive and corrective maintenance using internal resources and qualified external suppliers.
- Support installation, commissioning, qualification, and lifecycle management of facility systems and Good Manufacturing Practice equipment.
- Author and revise standard operating procedures, work instructions, maintenance plans, protocols, reports, and change controls for facility systems and activities.
- Plan and coordinate assigned facility repairs, upgrades, shutdown activities, and reliability improvement projects.
- Analyze equipment history, recurring failures, work order data, and maintenance trends to recommend reliability and performance improvements.
- Participate in deviations, investigations, root cause analyses, corrective and preventive actions, risk assessments, and change implementation associated with facility systems.
- Ensure assigned activities and documentation comply with current Good Manufacturing Practice, safety, environmental, radiation safety, and site quality requirements.
- Coordinate external vendors and contractors, communicate technical requirements, monitor work, and confirm completion and documentation.
- Prepare detailed protocols and reports and communicate project status, risks, timelines, and technical findings to internal stakeholders.
- Train or provide technical guidance to less experienced staff on facility systems, maintenance practices, safety, and Good Manufacturing Practice procedures.
- Partner with Operations, Quality, Engineering, Environmental Health and Safety, Metrology, and other teams to support continuous and compliant site operations.
- Experience in pharmaceutical, biotechnology, radiopharmaceutical, or other regulated manufacturing environments.
About the company
Telix Pharmaceuticals develops and commercializes diagnostic and therapeutic products that use targeted radiation to diagnose and treat cancer and rare diseases. Its pipeline covers urologic oncology (prostate and kidney cancers), neuro-oncology (glioma), musculoskeletal oncology (sarcoma), and bone marrow conditioning. The treatments work by delivering targeted radiation to diseased tissues, enabling more precise decisions for treatment and allowing for personalized therapy. The company differentiates itself through a global, robust supply chain and a focus on integrating diagnostic and therapeutic options to address unmet medical needs, along with strong commitments to patient care, ethical practices, and environmental responsibility. Telix’s goal is to improve quality of life and outcomes for patients by providing targeted, clinically meaningful diagnostic and therapeutic solutions that support better treatment decisions and personalized care.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Melbourne, Australia
Founded
2015
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Simplify's Take
What believers are saying
- FDA approved Pixclara on September 13, 2026, opening Telix's first brain-cancer imaging market.
- H1 2026 revenue reached $477 million, up 22%, with EBITDA rising 146%.
- BiPASS enrolled 350 patients and Telix aligned with FDA on a U.S. NDA pathway.
What critics are saying
- Telix still depends on FDA manufacturing acceptance for Zircaix resubmission in 2026.
- The $2.35 billion ITM deal brings dilution, debt, and integration strain through 2027.
- Novartis, with Lutathera and Pluvicto, attacks Telix in GEP-NETs and prostate therapy.
What makes Telix Pharmaceuticals unique
- Telix sells both diagnostics and therapies across the same radiopharmaceutical platform.
- Illuccix and Gozellix give Telix a commercial prostate imaging franchise in 24 countries.
- ITM adds isotope manufacturing, distribution, and lutetium-177 supply across more than 65 countries.
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Benefits
Annual Performance Bonus
Equity-Based Incentive Program
Paid Vacation
Paid Wellness Days
Hybrid Work Options
Remote Work Options
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 16%2 year growth
↑ 1%Telix buys ITM for $1.65B in 'supercritical' radiopharma M&A. September 21, 2026 | Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendocrine tumors. The asset was rejected by the FDA last month for manufacturing concerns. Australia's Telix Pharmaceuticals is buying privately held ITM Isotope Technologies Munich in a deal that one analyst firm is calling "supercritical," pointing to the global expansion and vertical integration opportunities that the agreement creates. Telix will acquire all of Germany-based ITM's shares for $1.65 billion upfront, according to a Monday announcement. The Melbourne-based company could also be on the hook for up to $700 million in certain milestone payments, including FDA approvals for ITM's lead asset, a lutetium-177-based radiopharmaceutical. Telix will also take on more than $300 million of ITM's debt at closing. "Overall, we are extremely bullish on the future growth prospect of the combined Telix-ITM entity," William Blair analysts wrote in a Monday morning note, calling the deal "supercritical" as it deepens Telix's manufacturing capabilities and "de-risks one of the most complex aspects of operating a radiopharmaceutical company." Telix and ITM expect to close the deal by the end of the year. The combined entity is projected to generate unaudited revenue and income topping $1.3 billion this year. Post-acquisition, Telix shareholders will own around 76.3% of the shares, while ITM backers will own around 23.7%. The transaction will further establish Telix as a "vertically integrated radiopharmaceutical company," the release stated, strengthened by ITM's manufacturing infrastructure and distribution network covering more than 65 countries. Last year, ITM's revenue hit $273 million. ITM's production capabilities are key to the agreement, particularly given the difficulties of manufacturing radiopharmaceuticals, according to William Blair. "By building a vertically integrated company with even greater control over the entire radiopharmaceutical value chain, we believe the transaction will allow Telix to further corner the industry and advance a range of product candidates from development through commercialization," the analysts added. And then there's ITM's radiopharmaceutical asset ITM-11, which targets the somatostatin receptor for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NET). The candidate was rejected by the FDA last month for issues with chemistry, manufacturing and controls at a third-party facility. No clinical safety or efficacy problems were identified, according to ITM. ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency's concerns. August 11, 2026 ITM is currently reviewing the FDA's feedback and working with its external partners to address the agency's concerns. The private biotech plans to resubmit its application, though timing will depend on its remediation talks with the regulator, according to a Monday morning presentation from the company. The buyout's contingent payments revolve around the initial and potential expansion approvals for ITM-11, as well as the asset's market performance. Beyond GEP-NET, ITM's asset is also being developed for lung and thymic neuroendocrine tumors, for which the investigator-initiated Phase 3 LEVEL trial is currently recruiting. Topline data for this study are expected in 2029. If approved, ITM-11 could propel Telix into the radiopharma commercial ring, facing off against Novartis and its two lutetium-177-based products Lutathera and Pluvicto. The former is approved for GEP-NETs and made $816 million last year, while the latter is indicated for metastatic castration-resistant prostate cancer with nearly $2 billion in 2025 revenues. Other Big Pharmas are advancing their own radiopharma assets, including AstraZeneca, Bristol Myers Squibb and Eli Lilly. Regeneron is also in the radiopharma ring, partnering with Telix in April for up to $4.3 billion to use the biotech's platform for four programs initially, with the option to add four more later on. At the intersection of radiation and precision, Novartis, Bayer, AstraZeneca and more hope to cash in on a radiopharmaceuticals market that could top $16 billion by 2033. May 12, 2025
ITM Isotope Technologies Munich and Telix Pharmaceuticals are merging following an unexpected FDA rejection for one of the companies, STAT News reported. Neither the rejected product nor financial terms were disclosed. Radiopharmaceuticals attach radioactive isotopes to targeting molecules, delivering radiation directly to tumour cells. The sector has attracted significant capital because the same platform can produce both diagnostics and therapies. Telix shares last traded at 12.59 on 18 September 2026, up 0.68%. The price predates the merger announcement. The timing suggests a defensive combination. FDA rejections reset launch timelines and force companies to reassess cash runways and manufacturing investments built for specific approval dates. ITM's isotope production capabilities remain valuable despite regulatory setbacks. Control over supply chains is crucial in radiopharma, where therapeutic isotopes decay rapidly and cannot be stockpiled.
Telix Pharmaceuticals has agreed to acquire ITM Isotope Technologies Munich for US$1.65 billion upfront on a cash-free/debt-free basis. ITM shareholders will receive approximately US$1.25 billion in Telix shares at US$11.84 per share, released as Nasdaq ADRs. ITM is the world's leading supplier of therapeutic radioisotopes, including lutetium-177, and the only producer of globally scaled commercial-grade Lu-177. The company delivered annual revenue of US$273 million in 2025. Additional contingent consideration of up to US$700 million is payable upon achieving regulatory approvals and sales milestones for ITM-11, a Phase 3-stage treatment for gastroenteropancreatic neuroendocrine tumours. The combined organisation expects to generate unaudited pro forma 2026 revenue exceeding US$1.3 billion. Upon completion, Telix shareholders will own approximately 76.3% of the merged entity. The transaction requires Telix shareholder approval and is expected to close by end of FY 2026.
The End Brain Cancer Initiative partners with Telix Pharmaceuticals for TLX101-Px (pixclara(r) and PDUFA awareness. September 03, 2026, 14:00 GMT SEATTLE, WA, UNITED STATES, September 3, 2026 / EINPresswire.com / - The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of September 11, 2026, for TLX101-Px (Pixclara (R)), an investigational PET imaging agent developed by Telix Pharmaceuticals to help doctors evaluate brain cancer. The End Brain Cancer Initiative (EBCI) has partnered with Telix Pharmaceuticals to develop and provide patient disease education around TLX101-Px (Pixclara (R)), what a PDUFA date is, and why it matters to patients. A PDUFA date is the target date established by the U.S. Food and Drug Administration (FDA) for completing its review of a new drug or medical product application and determining whether it can be approved for use in the United States. PDUFA stands for the Prescription Drug User Fee Act, which helps provide the FDA with resources to review new drug applications within established timelines. By the PDUFA target date of September 11th, the FDA is expected to complete its review and may approve TELIX's application, request additional information or requirements before approval, or take another regulatory action that affects the review timeline. A PDUFA date is therefore not a guaranteed approval date, but it is an important milestone for everyone following the development of a potentially meaningful new option for people affected, in this case, by brain cancer. Patients, caregivers, healthcare providers, and the general public who would like more information about TLX101-Px (Pixclara (R)) or PDUFA should visit https://endbraincancer.org/telix/. People can also directly contact EBCI's Clinical Research Coordinator and Patient Navigator, Shreya Prakash, at [email protected] or at 425-436-8688. About Telix Pharmaceuticals Telix Pharmaceuticals uses a radioactive isotope as a payload, attached to a targeting agent, such as a small molecule or antibody, with an affinity for targeted biomarkers on the surface of cancerous or diseased cells. Depending on the choice of radioisotope payload, either imaging or therapy can be delivered. This specificity of the targeting agent is designed to concentrate radiation at the tumor sites and to limit off-target tissue exposure. For more information, visit the company's website at https://telixpharma.com/. About the End Brain Cancer Initiative To support/donate to the End Brain Cancer Initiative's increased access and health delivery for patients, mission, services and programs, please visit EndBrainCancer.org and make a donation today. The End Brain Cancer Initiative (EBCI) is a 501(c)3 non-profit patient advocacy organization focused on disease education, awareness, outreach, increasing patient access and improving Standard of Care. The End Brain Cancer Initiative, formerly known as the Chris Elliott Fund (CEF), is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, treatments, specialists, and clinical trial participation. We believe that IMMEDIATE ACCESS to these options provides this patient community with the best HOPE for survival and sustained quality of life. We partner with industry, patients, researchers, advocacy groups, medical teams, hospital networks and others to educate patients and their caregivers so they can have empowered conversations with their medical teams. Learn more about the End Brain Cancer Initiative or how to sponsor this annual campaign at EndBrainCancer.org. Dellann Elliott Mydland, End Brain Cancer Initiative, 425-785-8489, [email protected] Dellann Elliott Mydland End Brain Cancer Initiative +1 425-785-8489 email us here Visit us on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above. You just read: September 03, 2026, 14:00 GMT EIN Presswire's priority is author transparency. We do our best to weed out false and misleading content. The content above is the sole responsibility of the author who makes it available. If you have any complaints, kindly contact the author above. Dellann Elliott Mydland End Brain Cancer Initiative +1 425-785-8489
The End Brain Cancer Initiative partners with Telix Pharmaceuticals for TLX101-Px (pixclara(r) and PDUFA awareness. SEATTLE, WA, UNITED STATES, September 3, 2026 / EINPresswire.com / - The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of September 11, 2026, for TLX101-Px (Pixclara (R)), an investigational PET imaging agent developed by Telix Pharmaceuticals to help doctors evaluate brain cancer. The End Brain Cancer Initiative (EBCI) has partnered with Telix Pharmaceuticals to develop and provide patient disease education around TLX101-Px (Pixclara (R)), what a PDUFA date is, and why it matters to patients. A PDUFA date is the target date established by the U.S. Food and Drug Administration (FDA) for completing its review of a new drug or medical product application and determining whether it can be approved for use in the United States. PDUFA stands for the Prescription Drug User Fee Act, which helps provide the FDA with resources to review new drug applications within established timelines. By the PDUFA target date of September 11th, the FDA is expected to complete its review and may approve TELIX's application, request additional information or requirements before approval, or take another regulatory action that affects the review timeline. A PDUFA date is therefore not a guaranteed approval date, but it is an important milestone for everyone following the development of a potentially meaningful new option for people affected, in this case, by brain cancer. Patients, caregivers, healthcare providers, and the general public who would like more information about TLX101-Px (Pixclara (R)) or PDUFA should visit https://endbraincancer.org/telix/. People can also directly contact EBCI's Clinical Research Coordinator and Patient Navigator, Shreya Prakash, at [email protected] or at 425-436-8688. About Telix Pharmaceuticals Telix Pharmaceuticals uses a radioactive isotope as a payload, attached to a targeting agent, such as a small molecule or antibody, with an affinity for targeted biomarkers on the surface of cancerous or diseased cells. Depending on the choice of radioisotope payload, either imaging or therapy can be delivered. This specificity of the targeting agent is designed to concentrate radiation at the tumor sites and to limit off-target tissue exposure. For more information, visit the company's website at https://telixpharma.com/. About the End Brain Cancer Initiative To support/donate to the End Brain Cancer Initiative's increased access and health delivery for patients, mission, services and programs, please visit EndBrainCancer.org and make a donation today. The End Brain Cancer Initiative (EBCI) is a 501(c)3 non-profit patient advocacy organization focused on disease education, awareness, outreach, increasing patient access and improving Standard of Care. The End Brain Cancer Initiative, formerly known as the Chris Elliott Fund (CEF), is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, treatments, specialists, and clinical trial participation. Healthcare Industry Today believe that IMMEDIATE ACCESS to these options provides this patient community with the best HOPE for survival and sustained quality of life. Healthcare Industry Today partner with industry, patients, researchers, advocacy groups, medical teams, hospital networks and others to educate patients and their caregivers so they can have empowered conversations with their medical teams. Learn more about the End Brain Cancer Initiative or how to sponsor this annual campaign at EndBrainCancer.org. Dellann Elliott Mydland, End Brain Cancer Initiative, 425-785-8489, [email protected] Dellann Elliott Mydland End Brain Cancer Initiative +1 425-785-8489 email Healthcare Industry Today here Visit Healthcare Industry Today on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. Healthcare Industry Today do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.