Validation Engineer III

Job description

Validation Engineer III

Job Title : Validation Engineer III

Description :

As a member of the R&D Validation & Applications Center (VAC) Engineering team, you actively participate on product development teams. Your contribution includes implementation of an efficient and thorough validation test matrix, including development of new test equipment and test methods, which ensures robust product specifications based on product design and intended applications.   Your responsibilities include authoring the validation test protocol,  test execution and authoring the report.  You participate in development of the product design specifications and risk assessments and coordinate testing for shelf life studies. You are responsible for planning, documenting and executing test method validations.  In addition, you collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer application inquiries. You effectively interact with other groups, such as Facilities, Engineering Services, Finance, EHS & Quality.

Travel:

·  Occasional travel to our manufacturing facilities <10%

 

Minimum Qualifications :

·  B.S. in engineering or applied science or equivalent plus 5-8+ years’ experience in a related technical area, or MS plus 3-5+ years
·  4+ years of experience with FMEA/risk analysis, product failure and root cause analysis 
·  4+ years of experience with process and product/system development and validations.
·  4+ years of experience authoring formal protocols and reports utilizing Good Documentation Practices.
·  3+ years of experience using statistical tools such as, Capability analysis, Gage R&R’s, DOE’s in Minitab
·  4+ years of experience with Product development process, or working on cross functional teams
·  4+ years of experience in the development and execution of test method validations

RSRMS

RSRMS

 

Preferred Qualifications :

·  Experience with equipment development, URS, GAMP, software validation, PLC and controls, plastics processing.
·  Working knowledge of quality principles including ISO, Quality Management Systems
·  Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements (CB Scheme/ UL testing) for systems used in biopharmaceutical processes.
·  Proficient in equipment calibration, trouble shooting and repairs
·  Experience with MilliporeSigma filtration, chromatography and Mobius products (Bioreactors, Mixers preferred)
·  Experience in managing Capital upgrades, involving Equipment design
·  Experience with change control methodology
·  Working knowledge of EHS guidelines,  and ergonomics principles
·  ASQ – CQE Certification a plus.RSRMS

RSRMS

RSRMS

RSRMS

 RSRMS

Job Requisition ID: 205495

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: Developer, Quality Manager, Product Development, Environmental Health & Safety, Testing, Technology, Quality, Research, Healthcare