CCI Manager Job Listing at Intertek in NJ (Job ID 14253)

Description

Container Closure Integrity Manager, Whitehouse NJ

Intertek, a leading provider of quality and safety solutions to many of the world's top-recognized brands and companies, is actively seeking a Container Closure Integrity Manager to join our Chemicals & Pharmaceuticals team in Whitehouse, NJ. This is a fantastic opportunity to grow a versatile career in pharmaceutical analytic testing.

Intertek's Chemical & Pharmaceuticals team brings quality and safety to life through regulatory guidance and supply chain assurance to support your unique pharmaceutical or biopharmaceutical outsourcing requirements. Over the last 20 years, our network of laboratories and regulatory experts have provided high quality custom pharmaceutical services ensuring Total Quality Assurance for some of the world's largest and most innovative pharmaceutical companies. Intertek is continually innovating and evolving to reduce risk for consumers, brands and organizations in every sector and industry around the world. We go beyond Testing, Inspection and Certification of products: we are a Total Quality Assurance Provider to industries worldwide. Our Purpose: Bringing quality, safety, and sustainability to life.

What are we looking for?

The Container Closure Integrity Manager is responsible to direct project activities regarding Container Closure System (CCS).  Independently conceive, develop, and execute all aspects of CCS characterization for Vials, Prefilled Syringes (PFS) and Cartridges to support drug products and combination products requirements. Will direct project activities regarding medical device testing and manage the performance of all medical device testing.

This position will travel at least 15% of the time.

Salary & Benefits Information

The base wage or salary range for this position is $180,000-200,000. Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons.  This position is bonus eligible.

In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more. 

What you'll do:

• Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems, focused on sterile dosage forms, based on patient, user, and technical requirements
• Perform testing services to ensure 510(K) compliances with the integrity of the devices
• Provide customized testing to support all lifecycle phases of combination products, from early concept and preclinical testing through final product qualification and management of ongoing commercial program support.
• Evaluate preconditioning and testing for compliance with ISO 11608 – Needle-Based Injection Systems for finished containers, needle design, automated systems, and accessibility for medical use
• Perform standard and customized functional, mechanical, force, dimensional/metrology and dose delivery/accuracy testing for drug delivery devices and products
• Provide technical leadership of primary packaging selection and validation, development of component specification for primary packaging components internal/external technology transfer including lifecycle management (LCM) activities
• Provide sterile packaging technical assistance for quality and regulatory activities including preparation of technical documents for regulatory filings
• Partner with device development team to ensure system level requirements for combination products are developed, verified, and validated in accordance with design controls and technical standards
• Develop strong cross-functional relationships with manufacturing, process development, quality control and quality assurance to enable effective resolution to technical issues and drive continuous process improvement while working with cGMP compliant standards
• Maintain and provide expert knowledge in container closure system qualification, in depth knowledge of regulatory requirements for container closure integrity (e.g. USP <1207>), active experience in container closure integrity test method development and validation
• Expert knowledge in functional characterization of CCS, in depth knowledge of force-based methods and optical analytical techniques
• Maintain familiarity to evolving regulatory and compendial changes and translate pharmaceutical and packaging industry trends to business opportunities

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties. 

Minimum Requirements & Qualifications:

• Bachelors in Analytical Chemistry, BSE Material Science and Engineering, Chemistry, Physics, or related fields with a minimum of 7 years hands on experience of USP 1207 testing
• Expert knowledge in parenteral manufacturing and CCS development in either pharmaceutical, medical device or biotech industry is required
• Significant knowledge in Extractables and Leachables (E&L) concepts, functional CCS characterization and Container Closure Integrity analysis according to a holistic CCI strategy
• Experience with mentoring, guiding and/or supervising of a team of scientists
• Experiences with regulatory submissions of biotechnology drug products
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions; able to influence without direct authority in multi-disciplinary teams; must be attentive to details and have excellent organization skills.
• IQ/OQ/PQ knowledge and ability to perform these standards
• In depth operational knowledge of medical device testing (Instron machine)
• cGMP regulatory knowledge and experience is a must 
• Model Intertek's 10X Energies at all times within the work place, practicing business the right way
• Be aware of, and adhere to, safety practices and policies to ensure your own safety, as well as the safety of others who may be affected by your actions at work
• Ability to work in fast-paced, multi-tasking environment with shifting priorities and demanding deadlines
• Must be detailed-oriented and able to effectively prioritize and organize workload, with efficient time management 
• Ability to communicate and interact effectively in verbal written and presentation formats
• Must possess the fundamental technical and administrative skills required to perform the job duties

• Must be customer focused and quality driven

• Ability to travel as business needs dictate

Intertek: Total Quality. Assured.

Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers' expectations, while engaging with our employees to be 10X in their performance and professional growth.

Intertek is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.

We Value Diversity

Intertek's network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.

For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email hr.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.

#LI-DNP

*Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume