5362- Cleaning Validation Specialist (CQV) / Senior Validation Engineer 2

Company: Tbwa Chiat/Day Inc
Location: Los Angeles
Posted on: January 23, 2025

Job Description:

DescriptionVerista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.Company 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 expertiseThe Cleaning Validation Specialist for Operations is responsible for ensuring the effective and compliant cleaning processes within manufacturing and operational environments in accordance with regulatory standards and company policies. This role involves the development, implementation, validation, and ongoing monitoring of cleaning procedures to ensure product integrity, safety, and regulatory compliance.
  • Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/software, and processes
  • Running test scripts and documenting results
  • Adherence with project schedule for all assigned activities
  • Maintaining clear, detailed qualification and validation records
  • Developing, reviewing, and executing testing documentation
  • Making recommendations for design or process modification based on test results when executing test scripts
  • General understanding of capital equipment implementation and process knowledgeRequirements:
    • Hands-on experience developing, executing, and reporting cleaning validation protocols (IQ/OQ/PQ) for manufacturing equipment and facilities.
    • Demonstrated ability to define acceptance criteria such as Maximum Allowable Carryover (MACO) and residue limits.
    • Experience selecting and validating cleaning agents, methods (CIP/SIP or manual cleaning), and residue testing techniques (e.g., HPLC, TOC, conductivity).
    • Expertise in performing risk-based assessments of cleaning processes to ensure compliance and minimize contamination risks
    • Experience investigating cleaning failures or deviations, conducting root cause analyses, and implementing corrective and preventive actions (CAPA)
    • Familiarity with creating and managing change control processes for updated cleaning procedures
    • Strong experience with cleaning validation for a variety of manufacturing equipment, including bioreactors, filtration systems, filling lines, and other process equipment used in pharmaceutical or biotech production
    • Proficiency in residue analysis techniques such as swab and rinse sampling, TOC, and UV/Vis spectroscopy
    • Proven track record of working with operations, quality assurance, and R&D teams to optimize and validate cleaning processes
    • Must be willing to work onsite in Los Angeles, CA
    • Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution
    • 5+ years of industry relevant experience
    • Experience in a pharmaceutical/FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
    • Communication Skills: Excellent oral and written communication skills, including presentations.
    • Ability to write clearly, concisely, and persuasively in a professional environment.
    • Demonstrated ability to interact effectively with all levels of the organization.
    • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
    • Strong problem-solving and critical thinking skills
    • Excellent organizational and time management skills
    • Strong attention to detail
    • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
    • Basic skills with EXCEL and PowerPoint
    • Experience with and tolerance for high levels of challenge and change
    • Proven attention to detail and organization in project work
    • Capable of working on assigned tasks without mentorshipFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.*Verista is an equal opportunity employer.National (US) Range$80,465 - $125,000 USDWhy Choose Verista?
      • 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.
      • Supplemental Life, Hospital, Critical Illness and Legal Insurance
      • Health Savings Account
      • 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 BereavementVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.For more information about our company, please visit us at Verista.com
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Keywords: Tbwa Chiat/Day Inc, Los Angeles , 5362- Cleaning Validation Specialist (CQV) / Senior Validation Engineer 2, Engineering , Los Angeles, California