More jobs:
Quality Control Engineer
Job in
Exton, Chester County, Pennsylvania, 19341, USA
Listed on 2026-06-01
Listing for:
Castle Creek Biosciences Inc
Full Time
position Listed on 2026-06-01
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Castle Creek Biosciences is a late-stage biotechnology company developing re-dosable cell and gene therapies. It is conducting a pivotal Phase 3 clinical trial of its lead candidate for patients with dystrophic epidermolysis bullosa (DEB). Castle Creek, a Paragon Biosciences portfolio company, is headquartered in Exton, Pennsylvania with additional office space in Chicago, Illinois. Learn more at
Role Summary
Will support the Quality Control department in technical projects, equipment qualification, statistical analysis of test results, data trending and reporting, investigations, root cause analysis, and supplier qualification. Applies good engineering practices to meet regulations to support clinical and commercial requirements.
Responsibilities
* Tracks, trends, and reports on key quality performance indicators (KPIs), including out of specification results, analytical test results, and environmental monitoring results
* Lead and execute risk assessments, gap assessments, FMEA, root cause analysis, and continuous improvement plans to ensure product quality and regulatory compliance
* Write and/or review technical non-conformance and deviation reports
* Design and execute corrective and preventive actions
* Provide technical input for control and validation strategies and effectively communicate strategies to internal and external stakeholders, including:
* Development of project design documentation
* Generating validation plans for equipment and test methods
* Compilation and review of validation protocols, executed data, and reports
* Execution of certain validation activities
* Testing data and documentation review
* Utilize proven statistical methods and tools to evaluate product data
* Schedule and manage the qualification of new equipment and periodic re-evaluation/requalification of existing equipment and systems
* Collaborate with Maintenance regarding maintenance routines, including calibration and preventative maintenance to ensure timely execution and proper documentation
* Act as a quality control SME during change control planning and execution for projects which require input of a technical nature
* Participate in analytical test procedure process mapping
* Perform project management and scheduling functions as it relates to execution of quality control activities and ensures clinical material testing schedules are adhered
* Provide software quality and validation leadership and be the SME for GXP computerized systems. Apply risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
* Interprets regulatory requirements for electronic and data integrity systems to identify, support and/or manage process improvement initiatives to ensure compliance with GxP regulatory requirements and Electronic Records/Electronic Signatures regulations. Participates in inspection readiness for regulatory inspections.
* Oversee and execute software quality and validation strategy in support of custom software systems to improve the overall accuracy, efficiency, and effectiveness of electronic computerized systems
* Evaluate and recommend assay compliance changes by keeping abreast of the requirements for compliance.
* Train personnel on quality control procedures and best practices
* Participate and support the external audit program for vendors related to GXP computerized systems, equipment, and processes as it relates to Quality Control
* Effectively identify and resolve complex system issues and appropriately communicate gating items to senior management and stakeholders.
Computer Skills
* Proficiency in use of Visio, PowerPoint, Microsoft Word, Excel, database management and statistical analysis software (JMP, Minitab, etc.).
* Experience with Solid Works a plus.
* Proficient in 21 CFR Part 11 and GAMP5 compliance requirements.
Education
* B.S. degree in Engineering, Computer Science or related technical field
* ASQ Certification is desirable
Experience & Requirements
* Minimum 5 - 7 years of experience working in a GMP Quality System within the Pharmaceutical or Biotech Industry.
* Minimum 5 years of relative work experience in risk…
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×