Quality Engineer I

Job description

Quality Engineer I

Your role:

The Cell Therapy Processing team is developing novel technologies to enable cell and gene therapy processes. The technologies are comprised of patented acousto-fluidics platforms to manipulate cell processes, such as concentration, washing, differentiation, sorting, and culturing. We are in search of candidates with experience or desire to obtain a position in validation planning of automated laboratory equipment and/or single-use disposables and materials. Travel to internal and external sites will be required as needed to communicate and perform these duties.

·  Creation of validation methods and test procedures
·  Preparation of test setups
·  Coordination with suppliers
·  Collection of data
·  Documentation of results for reporting
·  Frequent interfacing with testing laboratories, manufacturing suppliers, external development partners and internal stakeholders
·  Close coordination with our R&D team to smoothly transition advances in technology into future products
·  Participation in the creation of user requirement specifications and test, development and validation plans for these products as well

 

Who you are:

 

Minimum Qualifications:

·  Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering or any other Engineering/Life Science degree
·  1+ year(s) of hands on experience in product development of biomedical devices or equivalent Life Science field, process equipment or instrumentation working within a core steam structure
·  1+ year(s) of experience writing technical documentation such as SOP’s, qualification documents (IQ/OQ/PQ) and technical reports

 

Preferred Qualifications:

·  Master’s Degree
·  Experience with engineering change control processes and managing dynamic product designs in the transition to validated manufacturing
·  Proven experience in process validation and developing, writing and executing qualification test procedures including design, implementation and documentation of test programs
·  Customer-facing experience in your previous roles
·  Experience interfacing with vendors and developing qualified supply chains
·  Experience in the qualification and validation of engineering systems (IQ, OQ, PQ)
·  Proven experience in procedure generation
·  Medical device or other safety critical device development including specific requirements of GMPs, GAMP5, FDA QSR and ISO 9001 standards

RSMS

Job Requisition ID: 205389

Location: Wilbraham

Career Level: B - Recent University Graduate(<1 year of experien

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: Springfield MA
Job Segment: Medical, Product Development, Laboratory, Medical Device, Quality, Healthcare, Research, Science