Sr. Principal Quality Engineer

About the role

Quality Engineering 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.

Responsibilities

• Develop and execute standardized validation protocols for product, process, and cleaning validations within a contract pharmaceutical packaging environment with locations in LaVergne, TN and St. Louis, MO.
• Provide ongoing support for PQ/PV execution, Environmental Monitoring, and Temperature Validation.
• 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.

Qualifications

• 8–12 years of experience, preferred
• Bachelor’s degree in related field, or equivalent work experience, preferred
• Running or executing cleaning validations, preferred
• Quality validations experience, preferred

Travel: First 3–6 months will include a high level of travel; after initial project travel will be around 15%–25% of the time supporting both sites.

What is expected of you and others at this level

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects.
• Participates in the development of policies and procedures to achieve specific goals.
• Recommends new practices, processes, metrics, or models.
• Works on or may lead complex projects of large scope; projects may have significant and long-term impact.
• Provides solutions which may set precedent.
• Independently determines method for completion of new projects.
• Receives guidance on overall project objectives.
• Acts as a mentor to less experienced colleagues.

Pay

Anticipated salary range: $105,000 – $150,000. Bonus eligible.

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