CCIT Tech Lead: Regulated Lab Ops & Method Innovation

DDL, Inc. - Medical Device Package, Product and Material Testing; Eden Prairie (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Job summary

DDL, Inc. is a global testing facility focused on container closure integrity testing for medical device products.

The CCIT Technical Lead will guide regulatory-aligned laboratory operations and act as the SME for USP requirements while overseeing method development, validation, and routine testing activities. The role combines technical leadership, client-facing duties, and operational management to ensure high-quality, compliant services.

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.

Responsibilities

• 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).
• Design and develop CCI methods including vacuum decay, 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.

Skills

Leadership

Technical writing

Client-facing

Microsoft Office

Education

Engineering/Science degree

Tools

LIMS

QMS System

Job description

We are looking for a seasoned CCIT expert to build and elevate Container Closure Integrity Testing laboratory operations, someone who brings deep USP knowledge, hands‑on instrumentation experience, and the confidence to guide both clients and industry peers. In this role, you will shape CCIT strategy, stand up laboratory operations, and represent the field across working groups and technical forums, all while training, mentoring, and developing the technical staff who will deliver high‑quality, compliant analytical services. If you’re excited to drive CCIT innovation, influence industry practice, and build a high‑performing laboratory function, we want to hear from you.

Who We Are

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.

Compensation

This position has a starting base salary range of $120,000–$140,000 and includes eligibility to earn an annual bonus of up to 10% of base salary.

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 required

Experience in CDMO or contract testing laboratory environment required

Knowledge and understanding of CCIT instrumentation operation and test execution

Demonstrated leadership experience managing technical teams

Other Skills Required (computer, language, etc.): Microsoft Office, LIMS, QMS System

Ability to travel up to 20%

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
• Experience participating in industry working groups
  
  

Why Join Us

If you’re a team player who is looking for a sense of accomplishment, the opportunity to grow both personally and professionally, and a place to call home, then DDL is the place for you! At DDL, Inc., we strive to offer 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
• Paid Holidays
• PTO
  
  

It is DDL’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.