Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150

Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs.
Woburn, MA, USA
$87,780 - $129,826
Data
Senior Software Engineer
Hybrid
501 - 1,000 Employees
10+ years of experience
Healthcare · Biotech

Description For Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150

Verista is seeking a Validation Lead (Laboratory) Analyst to join their team. This role involves performing validation activities for various laboratory instruments, including MTS Tensile Tester, DS TOC Analyzer, LAL Test Equipment, Evolution Bio 260 spectrophotometer, Olympus CIX-100 Imaging Microscope, and Moisture Analyzer. Responsibilities include generating URS, reviewing and executing vendor protocols, creating wrapper protocols (IQ, OQ, PQ), CSV and DI protocols, performing method transfers, and independently leading clients through the Validation Lifecycle for identified equipment.

The ideal candidate will have a Bachelor's degree in Engineering, Life Sciences, or a related field, with 10+ years of relevant experience. They should have demonstrated experience in executing laboratory instrument validation activities, expertise in Data Integrity, and a strong understanding of FDA regulations and cGMP requirements. The role requires excellent documentation and communication skills, proficiency in Microsoft Office tools, and the ability to work as part of a team.

Verista offers a competitive compensation package, including a salary range of $87,780 - $129,826, along with various benefits such as medical, dental, and vision insurance, 401(k) with employer matching, paid time off, and tuition reimbursement. The company culture emphasizes empowering colleagues, committing to client success, and encouraging an inclusive environment where employees feel respected, engaged, and challenged.

This is a hybrid position, requiring onsite work in Woburn, MA for a large percentage of the time. The role offers the opportunity to work with a growing company in the life sciences industry, contributing to innovative solutions that help solve pressing healthcare challenges.

Last updated 21 days ago

Responsibilities For Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150

  • Perform validation activities for laboratory instruments
  • Generate URS
  • Review and execute Vendor protocols
  • Generate and execute wrapper protocols (IQ, OQ, PQ) CSV and DI protocols
  • Create Requirement documents from vendor manuals
  • Perform method transfers
  • Independently lead the Client through the Validation Lifecycle

Requirements For Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150

  • Bachelor's degree in Engineering, Life Sciences, or related field
  • 10+ years of role relevant experience
  • Demonstrated experience in executing laboratory instrument validation activities
  • Expertise in Data Integrity
  • Strong understanding of FDA regulations and cGMP requirements
  • Excellent documentation and communication skills
  • Proficiency using PC and Microsoft Office tools
  • Strong problem-solving and critical thinking skills
  • Excellent organizational and time management skills
  • Strong attention to detail
  • GMP and Good Documentation Practice
  • Intermediate skills with WORD
  • Basic skills with EXCEL and PowerPoint
  • Strong interpersonal skills
  • Experience with and tolerance for high levels of challenge and change

Benefits For Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150

Medical Insurance
Dental Insurance
Vision Insurance
401k
Commuter Benefits
Parental Leave
  • 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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