Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification)

Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification) Employer CSL Location Waltham, MA Start date Apr 1, 2026 categoriesView less categories Job Details Company

Job Details The Opportunity:

Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification) is an individual contributor role in the DDS department within CSL Technical Operations, which reports to the Director of Testing & Verification. The Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification)plays an important role in the medical device and primary packaging development process to deliver specialized testing results from exploratory characterization to design verification results to support regulatory submission packages. The Testing & Verification Team is involved in device development projects from early stage and is responsible for developing robust methods that can support product development, design verification, and commercial production Quality Control testing and executing testing.

The Role:

Develop, validate, transfer, and life cycle of test methods for vials, transfer devices, e.g., vial-to-vial transfer, syringes, needle-safety devices, autoinjectors, and on-body drug delivery systems. Conduct testing with appropriate methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules, e.g., stability pulls. Establish capabilities and technologies to support product development pipeline. Specify, design, and procure specialized test fixtures Author and review rigorous technical documents for inclusion in DHFs, to support regulatory submissions, and to address regulatory inquiry. Specify, install, qualify, and maintain test equipment. Support the laboratory operation such as sample inventory, equipment qualification, calibration, and maintenance. Schedule workload and communicate challenges, scheduling, testing conflicts or other issues to management in timely manner. Comply with CSL's quality assurance requirements and applicable regulatory requirements. Actively participate in team efforts to collaboratively deliver development project results. Use good judgement and laboratory practice to productively and safely execute testing and test method development in shared laboratory workspace.

Skills & Experience:

Knowledge of device standards, e.g., ISO, ASTM, ANSI, and USP for testing and verification of primary container and combination products. Excellent written and verbal communication skills including face to face and with professional media such video conference, telephone, email Experience working in a collaborative team environment; demonstrated skill influencing/building/promoting a productive culture of continuous improvement. Degree in Engineering, Natural Sciences, Pharmacy, or other relevant area. At least 5 years of related experience in medical device development and testing within the medical device/pharmaceutical industry. Preferred Qualifications Experience with practical applied statistics, SAS/JMP and/or Minitab software, solid modelling software, prototyping, optical measurement, mechanical testing, mechanical aptitude, PFS safety systems, autoinjectors About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about

CSL, CSL

Behring, CSL Seqirus and CSL Vifor visit csl/ and CSL Plasma at cslplasma/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit csl/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit csl/accessibility-statement. Company CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Areas of Expertise We focus and demonstrate global leadership in three distinct areas—rare and serious diseases; influenza vaccines; and iron deficiency and nephrology. Rare & Serious Diseases CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Vaccines As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries. Iron Deficiency & Nephrology With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women's health, we help patients affected by these conditions to live better, healthier lives. Company info Phone 610-878-4000 Location 1020 First Avenue King of Prussia Pennsylvania 19406 United States