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Insight Global CSV Engineer in Norwood, Massachusetts

Job Description

A midsize biotechnology company headquartered in Cambridge, MA is looking to bring on a CSV Engineer. The CSV Engineer will be working with be working 50% with the quality team and 50% testing, validating, and qualifying laboratory systems. This position will be responsible for providing quality oversight support and guidance for qualification and validation activities related to computer system validation for LIMS, Chromeleon, CTMS, Softmax, PH, Empower, and Emoda systems. The individual will provide QA Validation support and facilitate the development of validation plans, protocols, and summary reports for all stages of the validation of IT systems. Daily, the CSV Engineer will work with quality teams, create change controls, get protocols tested, authoring scripts, and performing software validation.

Daily Responsibilities Include:

1. Oversight for validation activities related to the implementation of IT systems

2. Collaborate with system and business owners during qualification activities of IT systems

3. Adhere to regulatory guidance, policies, and procedures for qualification, and validation of IT systems

4. QA Validation support and oversight for the development of user requirements, detailed design specifications, functional and configuration specifications, and requirements traceability matrices

Compensation:

$70/hour to $75/hour

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401K retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

   

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Skills and Requirements

5+ years of relevant experience in Biopharmaceutical or Pharmaceutical Industry

 Previous direct experience in validation, qualification, testing, mand documentation of laboratory systems.

 2+ years of experience with the following systems (from most to least important)

o LIMS (labvantage is preferred)

o Chromeleon

o CTMS

o Softmax

o PH

o Empower (Waters)

o Emoda Project Management Experience (managing timelines, agenda, meeting follow ups)

 Prior QA Validation experience null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.

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