Validation and Compliance Specialist

2 weeks ago


Westfield, Indiana, United States Vitalent Full time
ViTalent is a leading professional services firm focused on talent acquisition, development, staffing, and consulting within the Life Sciences sector. Our mission is to positively impact lives by serving as a long-term partner for both talent and organizations.

ViTalent is currently in search of Validation and Compliance Specialists with a strong background in large capital expenditure projects or greenfield facilities within cGMP environments to contribute to significant projects in the greater Indianapolis area.

Role Overview
  • Deliver expert technical guidance in commissioning, qualification, and verification (CQV) for large-scale capital projects involving new or modified equipment, facilities, and utilities, ensuring that CQV components are executed consistently and effectively. This includes the creation and execution of essential documents such as User Requirement Specifications (URS), System Boundary Definitions, Risk Assessments, Traceability Matrices, Design Qualification, Start-Up and Debug documentation, commissioning documents (FAT and SAT), and IQ/OQ/PQ, along with Turnover documentation.
  • Assist in the preparation of technical commissioning and qualification documentation for complex automated systems and processes, adhering to client quality standards, current Good Manufacturing Practices (cGMP), and relevant national/international regulations.
  • Review and verify system drawings, including as-built P&IDs and I&C diagrams, as well as electrical schematics, with support from electrical engineering teams.
  • Collaborate effectively with clients' quality representatives to address deviation investigations and resolve issues encountered during execution activities. Maintain comprehensive records of qualification and change control activities for future compliance audits.
  • Project assignments will vary based on specific customer requirements and project scope.
Qualifications:
  • A Bachelor’s degree or equivalent is required (STEM degree preferred).
  • Applicants must have authorization to work for any employer in the United States without visa sponsorship.
  • A minimum of 3 years of experience in commissioning, qualification, and validation within a regulated industry (pharmaceutical, biotechnology, medical device, etc.).
  • Experience with large greenfield or expansion capital projects in pharmaceutical and biotechnology manufacturing is essential.
  • Strong knowledge of Good Manufacturing Practices and Good Documentation Practices.
  • Familiarity with relevant regulatory requirements (e.g., FDA, EMA, cGMP).
  • Excellent analytical and problem-solving capabilities.
  • Strong written and verbal communication skills.
  • Ability to work independently as well as collaboratively within a team.
  • Proficiency in validation software and tools is advantageous.
  • Experience with automation and computerized systems validation is preferred.
  • Knowledge of Lean or Six Sigma methodologies is a plus.
Key Responsibilities:
  1. Commissioning:
    • Develop and implement commissioning plans for both new and existing equipment and systems.
    • Work alongside project teams to ensure that equipment is installed and operates according to design specifications.
    • Conduct functional testing and troubleshoot issues during the commissioning phase.
  2. Qualification:
    • Create and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems, including conducting FAT and SAT.
    • Perform risk assessments and identify critical process parameters.
    • Ensure adherence to regulatory standards and company policies throughout the qualification process.
  3. Validation:
    • Develop and execute validation master plans for processes, cleaning, and computerized systems.
    • Conduct validation activities, including process validation, cleaning validation, and computer system validation.
    • Document validation findings and offer recommendations for enhancements.
  4. Documentation and Compliance:
    • Prepare comprehensive reports and documentation for commissioning, qualification, and validation activities.
    • Ensure all documentation complies with regulatory and company standards.
    • Stay informed about industry regulations, guidelines, and best practices.
  5. Collaboration and Communication:
    • Engage closely with cross-functional teams, including quality assurance, engineering, production, and regulatory affairs.
    • Effectively communicate with internal and external stakeholders to ensure alignment on project objectives and timelines.
If you possess the necessary qualifications and are interested in this opportunity, we encourage you to submit your resume. We look forward to discussing your potential contributions to our team.

All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

#VTLS
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