CCI Technology Lead

HOW YOU WILL CONTRIBUTE (Overview & Key Responsibilities)

The CCIT Technical Lead is responsible for establishing, leading, and managing Container Closure Integrity Testing (CCIT) laboratory operations in a regulated environment. This role serves as the technical subject matter expert for USP and related regulatory requirements, while overseeing method development, validation, and routine testing activities. The position combines technical leadership, operational management, and client-facing responsibilities to support high-quality, compliant laboratory services.

• Develop and implement CCI strategies aligned with USP, FDA guidance, and industry best practices
• Lead and manage day-to-day CCI laboratory operations, including staffing, scheduling, and workflow optimization
• Serve as technical SME for CCI methods (vacuum decay, HVLD, helium leak detection, headspace analysis, etc.)
• Design and develop CCI methods including vacuum decay, high voltage leak detection (HVLD), helium leak detection, and headspace analysis - Define method parameters, detection limits, and acceptance criteria based on package configuration and risk assessment
• Lead internal and external audits for CCI, including FDA and client inspections
• Review, support and approve protocols, reports, deviations, and CAPA investigations
• Drive continuous improvement initiatives related to quality, efficiency, and lab performance
• Collaborate with Business Development to support client proposals, project scoping and technical discussions
• Execute and document method development, feasibility studies, and protocol-driven testing
• Lead and support method validation activities and method transfer projects
• Interpret test results, perform statistical analysis, and provide technical conclusions
• Author and review technical documentation including protocols, reports, SOPs, and validation summaries as it relates to CCI
• Collaborate with QA and regulatory teams to ensure compliance with cGMP, ISO 17025, and USP
• Identify opportunities and develop CCI studies for publication
• Build and maintain relationships with key technical leaders and customer stakeholders in CCI analysis
• Proactively develop knowledge of industry & technology as it applies to the area of CCI Analysis to effectively support organization in identifying and growing future analytical expertise
• Work proactively with the Commercial team to understand the voice of customer and put together a plan to bring the necessary capability and technology into the DDL organization to support our business
• Train, mentor, and develop technical staff including scientists, engineers, and technicians

WHAT YOU NEED TO SUCCEED (Minimum Qualifications)

• Bachelor’s or Master’s degree in Engineering, Chemistry, Materials Science, or related field
• 7+ years of experience in pharmaceutical, medical device, or regulated laboratory environment
• Direct experience with CCIT methods and USP preferred
• Experience in CDMO or contract testing laboratory environment
• Demonstrated leadership experience managing technical teams

OTHER SKILLS REQUIRED (computer, language, etc.)

• Microsoft Office
• LIMS
• QMS System

WHAT WILL SET YOU APART (Competencies Required)

• Strong knowledge of cGMP, FDA regulations, and quality systems
• Experience leading validation programs and regulatory audits
• Strong technical writing and documentation skills
• Familiarity with deterministic leak detection technologies
• ISO 17025 laboratory experience
• Six Sigma or Lean certification
• Client-facing or consulting experience

PAY

DDL offers a competitive salary along with a comprehensive benefits package that helps you and your family maintain health and well-being - both physically and financially. Our comprehensive benefits package includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Voluntary Accident, Critical Illness, and Hospital Indemnity Insurance
• Basic Life and AD&D / Voluntary Life and AD&D
• Short-Term Disability
• Long-Term Disability
• Pet Insurance
• Commuter Transit Benefits
• 401(k) Retirement Plan w/Safe Harbor Employer Contribution
• PTO