We are currently seeking qualified candidates for a Systems Engineer position with the Biologics Manufacturing segment of a leading multinational life sciences company. This is a permanent position that will be based out of the Greater Boston Area, Massachusetts, United States.
PURPOSE
Our Client is looking for a Systems Engineer with a software and hardware background to become a member of a rapidly growing team with a mix of engineers and biologists in the product development team for cell therapy manufacturing equipment.
RESPONSIBILITIES
- Designing, defining, updating, and implementing system requirements, system specifications, input/output processes and working parameters by using current systems engineering methods and technologies.
- Analyze and coordinate system partitioning (i.e. hardware/software partitioning) and total system integration by using systems engineering practices.
- Provide expertise and conducts evaluation, validation and verification activities.
- Document system requirements according to approved procedures and standards.
- Assist with industry-based standards testing for software.
- Utilize appropriate simulation and analysis tools.
- Work to ensure efficient and effective transfer of product into production.
EDUCATION, SKILLS & EXPERIENCE
- Degree in Systems, Biomedical, Software or equivalent engineering field: Bachelors with 10 years’ experience; Masters with 8 years’ experience; PhD with 5 years’ experience.
- Must have a desire to utilize their skills to solve complex technical problems in a hands-on manner, working in a fast-paced environment, and across multiple internal and external stakeholders and SMEs.
- Excellent core engineering skills and relevant industry experience.
- Experience performing multi-discipline, systems-level engineering development.
- Expertise in common engineering development tools for software development and mixed hardware and software systems.
- Experience with Life Sciences industry and with existing regulation (e.g. 21CFR part 11) and validation guidelines (e.g. GAMP5) is preferred; computer validation practices (e.g. CSV) is a plus.
- Familiarity with FDA and EMA requirements for manufacturing equipment and software.
- Strong communications and time management abilities.
- Ability to manage multiple tasks/projects.
- Experience working with CDMOs for research and manufacturing.
