Validation Engineer Lead

3 weeks ago


Athens, Georgia, United States Verista Full time
About Verista

At Verista, we believe in empowering growth and innovation within the scientific community. Our team of experts collaborates with world-renowned brands to provide innovative solutions and services to the life science industry.

We are committed to helping researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Our people-focused culture drives our ability to grow, and we thrive in a team environment that shares our mission to enable life sciences clients to improve lives.

Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Job Description

  • This Senior CQV Engineer role requires a strong understanding of capital equipment implementation and process knowledge.
  • The ideal candidate will have demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment) and authoring and executing FAT, SAT, IOQ, CSV protocols.
  • Responsibilities include coordinating scheduling, executing OPQ validation protocol, and validation protocol for cycle migration and Bowie Dick addition to autoclave.
  • PQ test cases include heat penetration studies for various liquid load configurations and standard operation procedure revision.
Requirements

To be successful in this role, you will need:

  • Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
  • Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV protocols
  • 6-10+ years of demonstrated CQV experience in GMP regulated environments
  • Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
  • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
  • Proven attention to detail and organization in project work
  • GMP and Good Documentation Practice training (may be completed at onboarding)
  • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
  • Basic skills with EXCEL and PowerPoint
  • Strong interpersonal skills and clear communication capabilities
Benefits

As a valued member of our team, you can expect:

  • 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 (We have fun)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Estimated Salary: $87,780 - $134,153



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