Senior Validation Engineer

2 weeks ago

Concord North Carolina, United States Verista Full time
About the Role

Verista, a leading provider of innovative solutions and services to the life science industry, is seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our validation team, you will play a critical role in ensuring the quality and integrity of our systems and processes.

Key Responsibilities
  • Support the validation activities for local and global systems, ensuring compliance with regulatory requirements and company standards.
  • Coordinate with technical evaluation teams to assess new and existing systems from a data integrity and CSV perspective.
  • Perform data integrity gap assessments and develop remediation plans for computerized systems.
  • Responsible for creating CAPAs/Deviations and Change Requests in ServiceNow and Trackwise.
  • Coordinate with cross-functional teams to ensure alignment of validation activities.
  • Manage validation and documentation related to complex computer systems, multiple pieces of equipment, large upgrades, and extensive product updates.
  • Perform functions of validation engineer, including drafting Validation Plans, Requirements, Test Cases, and Summary Reports.
  • Change management process owner for validation involving new or modified equipment, processes, procedures, and products.
Requirements
  • Experience in developing and maintaining validation documentation, including validation plans, test protocols, test scripts, and summary reports, aligned with company SOP and regulatory standards.
  • Experience using HPALM for authoring and executing test scripts.
  • Experience in performing/supporting computer validations associated with SDLC deliverables.
  • A minimum of a Bachelor's degree in an Engineering or Scientific degree and 7-10+ industry experience.
  • Must be willing to work onsite in Concord, NC.
  • Obvious business maturity and interpersonal skills to effectively communicate and collaborate.
  • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the organization.
  • Proven attention to detail and organization in project work.
  • Capable of working on assigned tasks without mentorship.
Preferred Qualifications
  • 10+ years' experience in GMP regulated environment (with internship or co-op work experience considered as part of that experience).
  • Direct experience authoring/editing/executing validation documents for laboratory equipment (Cat. A, B & C).
  • Expert knowledge of FDA regulations, ISPE guidelines, and ISO standards, including Good Documentation Practice (GDP) in pharmaceutical environments and 21 CFR Part 11.
What We Offer
  • High growth potential and fast-paced organization with a people-focused culture.
  • 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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