CCI Technology Lead

CRYOPAK INC•Eden Prairie, MN

9d•$120,000 - $140,000

About The Position

DDL, Inc. is a third-party testing facility dedicated to helping medical device and pharmaceutical companies across the globe bring products to market. For over 30 years, DDL has provided extraordinary customer service and specialized testing expertise to the medical device, pharmaceutical, and consumer goods industries for our clients’ safety and efficacy testing. We help save lives by providing the highest standards for package, product and material, and Container Closure Integrity testing. 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 <1207> 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.

Requirements

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 <1207> preferred
Experience in CDMO or contract testing laboratory environment
Demonstrated leadership experience managing technical teams
Microsoft Office, LIMS, QMS System

Nice To Haves

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

Responsibilities

Develop and implement CCI strategies aligned with USP <1207>, 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 <1207>
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