Senior CSV Engineer (Polarion) / Senior Validation Engineer 2

Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs.
Cambridge, MA, USA
$80,465 - $121,170
Data
Senior Software Engineer
Remote
501 - 1,000 Employees
8+ years of experience
Healthcare · Biotech

Description For Senior CSV Engineer (Polarion) / Senior Validation Engineer 2

Verista is seeking a Senior CSV Engineer with ALM experience, preferably with Polarion. The ideal candidate should have strong lab informatics experience, particularly with LabVantage, and be well-versed in CSA methodology. Key responsibilities include handling projects such as calculation validations in LabVantage, instrument integration, JMP/Statistica integration, data migration, and system integration.

The role requires:

  • Bachelor's degree in Engineering or Scientific field with 6-10 years of relevant experience
  • Significant experience with ALM software, preferably Polarion
  • Strong Lab Informatics and LIMS (LabVantage) experience
  • Excellent communication and collaboration skills
  • Ability to work independently on assigned tasks
  • Experience in authoring/editing/executing validation documents for laboratory equipment
  • Knowledge of FDA regulations, ISPE guidelines, and ISO standards

Verista offers a competitive benefits package including:

  • Competitive pay with performance-based incentives
  • Health insurance (Medical, Dental & Vision)
  • Life and Disability Insurance
  • 401(k) Retirement Plan with employer matching
  • Paid Time Off and Holidays
  • Tuition Reimbursement
  • Employee Recognition and Referral Program
  • Paid Parental Leave and Bereavement

Verista values empowerment, client success, courage, inclusivity, and continuous learning. Join a high-growth, fast-paced organization with a people-focused culture and make an impact in the life sciences industry.

Last updated 20 days ago

Responsibilities For Senior CSV Engineer (Polarion) / Senior Validation Engineer 2

  • Handle projects such as calculation validations in LabVantage
  • Perform instrument integration with LabVantage
  • Integrate JMP/Statistica with LabVantage
  • Manage data migration from legacy stability system into LV and legacy system decommissioning
  • Integrate Sarepta LIMS with CMO LIMS
  • Work on Splashlake projects

Requirements For Senior CSV Engineer (Polarion) / Senior Validation Engineer 2

  • Bachelor's degree in Engineering or Scientific field
  • 6-10 years of relevant experience
  • Significant experience with ALM software, preferably Polarion
  • Strong Lab Informatics and LIMS (LabVantage) experience
  • Excellent communication and collaboration skills
  • Experience in authoring/editing/executing validation documents for laboratory equipment
  • Knowledge of FDA regulations, ISPE guidelines, and ISO standards
  • Experience with Good Documentation Practice (GDP) in pharmaceutical environment
  • Knowledge of 21 CFR Part 11

Benefits For Senior CSV Engineer (Polarion) / Senior Validation Engineer 2

401k
Commuter Benefits
Dental Insurance
Education Budget
Medical Insurance
Parental Leave
Vision Insurance
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

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