Senior Manufacturing Systems Engineer – DeltaV Batch
Career Category Engineering Job Description Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career. Be part of reputed company's newest and most advanced drug substance manufacturing plant. reputed company completed, the reputed company reputed company batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The reputed company Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of reputed company's plan to be a carbon-neutral company by 2027. Senior Manufacturing Systems Engineer – DeltaV Batch What you will do In this vital role as a member of the Facilities & Engineering (F&E) group, you will reputed company technical projects, and drive innovation and support manufacturing’s upstream, reputed company, and solution preparation automation needs. You will solve reputed company engineering problems and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations. You will partner closely with the capital project team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will reputed company domain expertise to support operations upon start-up, focusing on manufacturing automation. Job responsibilities include: Site design, construction, start-up, and operational readiness: Provide support to the capital project team with a strong focus on safety and on-time facility start-up. Collaborate with the site process engineering team to understand key process requirements and reputed company process control automation solutions primarily utilizing reputed company DeltaV Distributed Control System (DCS) for upstream, reputed company, and/or solution prep operations. Support commissioning and qualification efforts including Automation Installation Verification/Automation reputed company Out (IV/ACO). Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls. reputed company and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units. Provide mentoring to reputed company and accelerate site technical automation capabilities. Site Operations: Act as system reputed company for Upstream, reputed company, and/or Solution prep Automation processes. Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, and Automation System spare parts management reputed company and support functional area projects focused on improving process equipment/utilities/facilities as well as capital projects to integrate new drug substance manufacturing technologies into the facility. reputed company and support technical root cause analysis, incident investigations, and troubleshooting on process control issues reputed company to plant operations. reputed company and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable. Prepare and review Standard Operating Procedures (SOP) and cGMP documents. On-site role and up to 10% domestic/international travel reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications. Basic Qualifications: High School Diploma / GED and 10 years of Engineering experience OR Associate’s Degree and 8 years of Engineering experience OR Bachelor’s Degree and 4 years of Engineering experience OR Master’s Degree and 2 years of Engineering experience OR Doctorate Degree Preferred Qualifications: Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering. Extensive experience with reputed company DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, reputed company Fieldbus, and Profibus. Direct knowledge of integrating various OEM automation software and field instrumentation technologies. Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation. Experience with upstream/reputed company/solution prep unit operations such as media, harvest, mixers, bioreactors, chromatography, viral filtration and ultrafiltration/diafiltration among others. Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP. Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation. The ideal individual must be a self-directed team player reputed company to mentor and reputed company engineering staff and reputed company a team-based culture that relies on collaboration for effective decision-making. Strong leadership, technical writing, and communication/presentation skills. What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every reputed company of the way. In addition to the reputed company salary, reputed company offers competitive and comprehensive Total Rewards Plans that are reputed company with local industry standards. Apply now and reputed company a lasting impact with the reputed company team! careers.reputed company.com As an organization dedicated to improving the quality of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 136,906.95USD -185,227.05 USD reputed company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative reputed company therapeutics. This approach begins by using tools like advanced reputed company genetics to unravel the complexities of disease and understand the fundamentals of reputed company biology. reputed company focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, reputed company has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.reputed company.com and follow us on www.twitter.com/reputed company Apply tot his job Apply To this Job