Offers “Merckgroup”

Expires soon Merckgroup

Principle Systems Engineer

  • Internship
  • Bedford (Bedfordshire)

Job description



Principle Systems Engineer

Your Role:

We are seeking a Senior Systems Engineer with a software and hardware background to join our product development team for cell therapy manufacturing equipment.  As a Senior Systems Design Lead, you will manage various engineering aspects of development, tech transfer, and launch of a novel, industry-leading manufacturing system for personalized/autologous cell therapies.  In this role, you will engage in all facets of product development including concepting, documentation, design, prototyping and transfer to manufacturing to meet the needs of Millipore Sigma’s quality systems and a complex regulatory environment.  The candidate must have the drive to solve complex technical problems, work in a fast-paced environment, and across multiple internal and external stakeholders and subject matter experts.

 

·  Lead activities in the arena of manufacturing platform development for autologous cell therapy.
·  Collaborate with a diverse group of engineers, biologists, software designers, end-users and external suppliers.
·  Participate in the translation of user and functional requirements to design specification, concepts and directions.
·  Assist in the collection and documentation of user and functional requirements.
·  Design within parameters of applicable compliance and human factors standards for ease of marketing.
·  Execute project scope throughout the concepting, design and pilot phases.
·  Review technical documentation produced by colleagues, including conceptual design, mechanical drawings, and technical reports.
·  Adhere to high-quality industry standard development principles while delivering solutions on-time and on-budget.
·  Respond to malfunctions to identify root issues and drive solutions in the product design.
·  Adhere to our Quality System for activities including design control, risk management, and change control.
·  Generate and review documentation required for manufacturing technical transfers.
·  Support of activities pertaining to market-readiness of product, including qualification activities.

 

Who You Are:

Minimum Qualifications

·  Degree in Chemical, Electrical, Computer Science, Bioprocessing or related engineering field: Bachelors with 10+ years’ experience, Masters with 8+ years’ experience, PhD with 5+ years’ experience indesigning integrated systems for medical or pharmaceutical industry
·  Sound knowledge of design, development and manufacturing transfer
·  Industry experience in automation for process equipment with a proven track record for designing, implementing and supporting automation solutions for complex multidisciplinary problems
·  Familiarity with FDA and EMA requirements for manufacturing equipment and software, including 21CFR part 11 and GAMP5 guidelines, and UL and EMC certifications.
·  Advanced understanding of mechanical, electrical and software systems, focus on mechanical
·  Strong innovation and creativity in design solutions
·  Strong leadership and communication skills with ability to make decisions
·  Independent management of time across multiple tasks/projects
·  Quality and accuracy of documentation

 

Preferred Qualifications

·  Advanced understanding of cell culture principles and bioreactor-based platforms
·  Experience working with CDMOs for research and manufacturing
·  CAD Skills (Solid Edge preferred)

Job Requisition ID: 196930

Location: Bedford

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Nearest Major Market: Boston
Job Segment: Medical, Product Development, Biology, Pharmaceutical, Healthcare, Research, Science, Quality

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