Validation Engineer Job at Yoh, A Day & Zimmermann Company

Yoh, A Day & Zimmermann Company Devens, MA

Devens, MA
HYBRID
12 month W2 contract (with potential to extend or transition to perm)
Pay rate: $55-62/hour depending on experience level

4 days onsite/ 1 day work from home (manager will adjust as the business and project needs are required)

Some of the Your Responsibilities:
  • Qualify QC equipment
  • Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, risk assessments, qualification summary reports
  • Own change controls specific to the qualification of QC instruments and its associated software
  • Update the asset management database to reflect new assets, calibrations, preventative maintenances
  • Author instrument operational SOPs as needed
  • Assist with onboarding/relocating instruments
  • Decommission equipment as needed
  • Coordinate/interface/host vendors on site
  • Champions qualification deviations, identifying root causes and Corrective Actions/Preventive Actions (CA/PAs)
  • Acts as the liaison between Digital Plant (IT) and lab departments
Skills or Requirements:
  • Quality management system experience that includes document control/management, change controls, investigations, deviations, , asset management database
  • Knowledge of cGMP regulatory requirements
  • Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
  • Demonstrated success in cross functional influencing, strong communication, and collaboration skills
  • Must have equipment validation experience
  • Must have GMP experience
  • Must have change control experience
Education/Experience:
  • Bachelor’s degree in relevant scientific, engineering, or computer-based area with a minimum of 4 years’ experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience
What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

  • Medical, Dental & Vision Benefits
  • 401K Retirement Saving Plan
  • Life & Disability Insurance
  • Direct Deposit & weekly ePayroll
  • Employee Discount Programs
  • Referral Bonus Programs
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities [1]to contact us if you are an individual with a disability and require accommodation in the application process.

Links:
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[1] https://www.yoh.com/applicants-with-disabilities
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