The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
The Engineering Validation Specialist will be responsible for providing commissioning, qualification, and validation support with regard to site equipment, processes, an/or systems. This role will validation industrial processes in order to maintain compliance and meet project deadlines. In addition, he/she will be responsible for their day-to-day activities including, execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems, and processes in support of personalized cell and gene therapy production through safe and compliant manufacturing and testing operations according to cGMP requirements. This role requires CQV and engineering experience, ability to work independently, drive effective communication, coordination, and collaboration across relevant cross functional groups in support of the CQV program.
- Participate in providing a planned, documented and managed approach to the commissioning, qualification testing of validated systems and equipment to include associated maintenance activities.
- Responsible for assigned CQV projects, status reports, and collaborate with other departments and/or outside contractors/vendors to complete tasks assigned
- Supports quality investigations, CAPAs and corrections to supporting documentation as needed
- Supports any required remediation efforts and associated CAPA plans as assigned by CQV management.
- Authors, owns and executes CQV protocols, summary reports and data acquisition in compliance with CBM standard operational procedures and regulatory requirements
- Participates in the creation, revision, and review of controlled documentation as it pertains to CQV processes and requirements
- Supports the authoring of risk assessments, FMEAs, periodic qualifications, project plans, master plans and annual product reviews as assigned
- Understands existing system boundaries and assists CQV management with establishing any new system boundaries, scope of work and commissioning execution plans
- Supports project specific written commissioning and qualification procedure for new system and continue re-validation efforts on existing systems
- Other duties as assigned
- Bachelor’s degree in science, engineering or equivalent technical discipline is required
- Minimum of 2 years’ relevant experience required in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance or manufacturing compliance
- Proven work experience in validation required or Current Good Manufacturing Practices (cGMP)
Knowledge, Skills, and Abilities:
- Strong written and oral communication skills.
- Proficient in use and application of computer software, such as MS Excel, MS Access, MS Word, and Google applications.
- Experience with using MS project is a plus
- High level of "attention to detail"
- Possesses high level of interpersonal skills and work collaboratively in a team environment.
- Experience in use of calibration asset management software (SAP CalMan, Blue Mountain Regulatory Asset Manager, etc.)
- Experience with Quality Management Systems for controlled documentation (Veeva experience is a plus)
- Experience utilizing Valgenesis validation software is a plus
- Ability to communicate effectively with management, coworkers, clients, client operations, vendors, contractors, and other stakeholders
- Must be highly organized in order to operate in a fast-paced dynamic work environment while adhering to established deadlines of projects
- Must have a solid team player attitude and flexibility to accept rapid changing priorities while remaining professional at all times