Validation Engineer

Leiters Inc-posted 3 months ago
Full-time • Entry Level
Inverness, CO
101-250 employees
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The Validation Engineer reports directly to the Validation Manager. The role is responsible for acting as a SME for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, shipping validation, and program maintenance. The Validation Engineer will work closely with Quality, Engineering, and Operations teams to ensure processes, equipment, and systems are compliant, reliable, and inspection-ready. This role ensures all systems operate under regulations to ensure the production of quality products for the Company’s 503B cGMP manufacturing facility.

  • Works on projects/matters in a supporting capacity.
  • Utilizes Project Management skills to plan and coordinate efforts with a cross-functional team.
  • Completes tasks in a timely fashion and communicates task status to management and/or project team.
  • Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, and CAPAs.
  • Coordination of Validation activities with stakeholders.
  • Supports in writing and executing protocols for Validation work.
  • Identifies and resolves non-conformances/discrepancies encountered during IQ/OQ/PQ execution and work with cross function team to implement mitigation solutions.
  • Generates reports and summarizes results, including confirming the document is suitable to be shared with regulatory agencies.
  • Supports creation or revision of Validation templates for protocols and reports.
  • Supports creation and review of Engineering Documentation (URS, FS, SAT, FAT).
  • Supports project work as a specialist on complex technical matters.
  • Bachelors degree in STEM field required; i.e. engineering, chemistry, or relevant industry experience.
  • 4+ Years of validation experience preferably in a highly regulated environment.
  • Experience in project management preferred.
  • Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.).
  • Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through.
  • Willingness to support tasks outside normal job description, as needed.
  • Ability to create technical and professional documents.
  • Strong attention to detail and accuracy.
  • Ability to multi-task, with strong organization and time-management.
  • Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis.
  • Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
  • Proficient written, verbal and oral English communication skills are required.
  • Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
  • 100% employer paid medical plan.
  • Dental & Vision insurance options including FSA & HSA.
  • Employer Paid Life Insurance & Employee Assistance Program.
  • Short Term & Long-Term Disability Insurance.
  • Up to 4% 401K Matching (100% vested on day one!).
  • Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
  • $5,250 Annual Tuition Reimbursement after 6 months.
  • $1,000 Referral Bonus Program with no limit.
  • Eligible for annual bonus program.
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