Job Title: Automation Engineer II
Requisition ID: 123483BR
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Viral Vector Services is a dynamic gene and cell therapy CDMO that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
Location/Division Specific Information
Greater Boston Area – Seated in Cambridge or Lexington, long term seated in new commercial facility in Plainville, MA - Approximately 20% travel to Alachua, FL and other local facilities.
How will you make an impact?
The Automation Engineer II will be responsible for supporting the new VVS commercial facility in Plainville, MA with a scope encompassing automation systems for GMP manufacturing, process development, quality control, and warehouse operations. The initial focus of the position will be supporting the execution of a large capital facility project from detailed design, procurement and construction for a state-of-the-art new commercial manufacturing facility. This role will later transition into primarily a manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing, laboratory and warehouse operations in Plainville, MA. The position will be initially based in Lexington, MA during design/construction and will ultimately be based in Plainville, MA.
What will you do?
• Responsible for the support of clinical and commercial drug manufacturing of gene therapy products.
• Leads automation engineering activities during tech transfers of new products into the manufacturing facility and provides continued support throughout manufacturing campaigns.
• Designs, specifies, and supports manufacturing equipment and analytical equipment including implementing modifications to improve operational performance and product quality.
• Create and maintains relationships with other VVS sites to develop and promote engineering best practices and ensures compliance with VVS SOP's, safe work practices, and cGMP regulations.
• Involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.
How will you get here?
• B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical, automation engineering or related engineering field – preferred. A combination of education and experience will be considered.
• Direct experience supporting pharmaceutical manufacturing processes within an FDA/EMA regulated environment – strongly preferred.
Knowledge, Skills, Abilities
• Understanding of electrical standards and local requirements and control system hardware
• Experience with DCS and/or PLC coding including but not limited to DeltaV, Allen Bradley, and Siemens
• Experience with systems such as ESXi, Syncade, OSI PI, Infobatch and Labwatch
• The candidate must have a general understanding of cGMP standards and industry engineering best practices
• Working knowledge of equipment/hardware/software testing and associated protocols and lifecycle documentation requirements
• DCS/PLC/Automation system installation and support
• Strong understanding of applicable regulatory requirements
• Technical documentation review and revision experience
• Strong interpersonal and communications skills; written and oral
• Working with both hands-on and remote based staff
• Strong ability to work independently
• Comfortable supporting concurrent issues and working in an exciting, fast-paced environment
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
To Apply, please click the following link: https://thermofisher.contacthr.com/77016646
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