Sr. Principal Quality Engineer
About The Position
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services. This role would be accountable for developing and executing a standardized cleaning validation protocol for the LaVergne site, followed by deployment of the same protocol at the St. Louis site. This role would be accountable for the development and execution of standardized validation protocols for product, process, and cleaning validations within a contract pharmaceutical packaging environment with locations in LaVergne TN and St. Louis MO. This work is critical to sustaining compliant operations and aligning validation practices across both facilities. The role would also provide ongoing support for PQ/PV execution, Environmental Monitoring, and Temperature Validation. CHPS is a multi-site FDA registered custom contract pharmaceutical packaging facility. Specific emphasis for this role is to: Develop and execute cleaning validation master plans, protocols, and reports. Design cleaning validation studies based on risk assessments and product/equipment characteristics. Establish scientifically justified acceptance criteria for residues and contaminants. Support lifecycle management of validated cleaning processes.
Requirements
- 8-12 years of experience
- Bachelor's degree in related field, or equivalent work experience
- Running or executing cleaning validations
- Quality validations experience
Responsibilities
- Develop and execute cleaning validation master plans, protocols, and reports.
- Design cleaning validation studies based on risk assessments and product/equipment characteristics.
- Establish scientifically justified acceptance criteria for residues and contaminants.
- Support lifecycle management of validated cleaning processes.
- Provide ongoing support for PQ/PV execution, Environmental Monitoring, and Temperature Validation.
Benefits
- Medical, dental and vision coverage
- Paid time off
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
