Job Title: Principal Engineer (Delta V Automation)
Location: Onsite (Building 30), 5 days per week, regular business hours (8:30 AM - 5:30 PM)
Duration: 3-year contract
On-call requirement: Minimal (rotational approximately every 7 weeks; typically 1-hour calls weekly)
The ideal candidate for the Principal Automation Engineer (Delta V) role will have extensive expertise in Delta V batch control systems, with a minimum of 4–5 years of direct, hands-on Delta V experience specifically in pharmaceutical manufacturing environments. They should demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V. Candidates should ideally hold a Bachelor’s degree (Chemical, Electrical, Automation Engineering, Computer Science, Electronics, or similar technical field). However, substantial practical Delta V experience can outweigh formal educational qualifications. A strategic mindset, excellent troubleshooting skills, and strong interpersonal capabilities are crucial, as the role involves frequent collaboration across various teams. Experience in PLC systems and Delta V system administration is beneficial but not mandatory. Candidates must show a track record of stability in their previous employment, with demonstrated capacity for maintaining long-term roles.
Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Responsibilities: - Work cross-functionally with individuals and project teams in Marketing, Operations, and Development - Create and assess product requirements to determine technical coverage and proper integration different subsystems. - Create and execute to project plans and schedules - Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. - Provide deep technical assistance for junior engineers. Skills: - BS in Engineering and previous experience in a medical device industry - 10 years current experience with engineering processes and procedures. - Led projects from development through the 510k and PMA approval process. - Strong background in engineering and commercialization of electro-mechanical medical devices. - Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. - Experience in drug/device combination product design and development - Familiar with the following standards: o Quality System Regulation ? 21CFR820 o Risk Management ? ISO 14971 o EU Medical Device requirements ? Council Directive 93/42/EEC o Medical Electrical Equipment ? EN 60601 - Small scale device assembly experience. - Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. - Strong problem solving, risk assessment, and risk management skills. - Must be capable of working on multiple projects in a deadline driven environment. VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
Basic Qualifications
Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience
Top 3 Must Have Skill Sets:
o Emerson Delta-V DCS system with batch control and recipe management
o System Integration using OPC, Profibus, EIP, WIOC, and DeviceNet technologies.
o DeltaV Virtual infrastructure configuration, management, and troubleshooting
...bulk trucking company based out of Belvidere, Illinois Role Description This is a full-time on-site role for a CDL A Truck Driver located in Belvidere, IL. The Truck Driver will be responsible for transporting goods and materials, ensuring safety and timely delivery...
...Medi Home Hospice is seeking an experienced Full-Time Administrator for our Hospice team in Danville (Pittsylvania) VA , area.... ...end close. Job Requirements Licensed as Registered Nurse (RN) in VA state(s) serviced by the agency strongly preferred or Bachelor...
Duration : 05 Months (Possibility of extension/conversion based on performance and budget) Client : One of the largest Aerospace and Defense companies in the US Overview : We are looking for a reliable and detail-oriented HR Assistant to support our employee...
We, at 365 Health services are actively seeking qualified and dedicated Personal Care Assistants that can provide exceptional care to our patients. An experienced personal care professional provides personalized assistance and support to individuals, focusing on their physical...
...Are you an experienced Inpatient Coder looking for a remote role where your expertise truly matters? Join a collaborative and forward-thinking healthcare organization dedicated to accuracy, compliance, and excellent patient care. Inpatient Coder Responsibilities...