POSITION SUMMARY:

In this exciting role as an Validation Senior Quality Engineer, you will design or plan protocols for equipment or processes to produce tissue-based products, biologic drug products and medical device products meeting internal and external purity, safety and quality requirements. This position will ensure compliance with all applicable, regulatory requirements, company policies, and standards. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage projects, efforts, and changes of moderate complexity and scope including but is not limited to, process performance qualifications, sterilization validations, stability studies, packaging simulated distribution studies, equipment validations, etc.
• Communicate quality standards and requirements within the organization.
• Project management with a focuses on planning and organizing a project and its resources from initiation through planning, execution, monitoring and control through closure.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Participate in continuous improvement activities that directly impact performance measures.
• Leads product quality investigations in support of CAPA, complaints and nonconforming material processes.
• Collect, analyze and interpret statistical data, performs analyses and provide reports as required.
• Takes an active role in leading, and reviewing design and manufacturing changes.
• Assists with internal and external audit activities.
• Leads Quality Assurance and product quality improvements in cross-functional initiatives.
• Supports day-to day manufacturing activities.
• Specialize in the areas of production control, incoming material, product evaluation and reliability, inventory control, and development as they apply to product or process quality.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Overlook and participate change approval process for risk assessment, verification, and validation.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

PROBLEM SOLVING:

• Performs advanced areas of work for the professional field
• Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems.
• Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results

DECISION MAKING/SCOPE OF AUTHORITY:

• Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions
• Receives technical guidance only on unusual or complex problems or issues
• May manage elements/portions of a budget/project

SPAN OF CONTROL/COMPLEXITY:

• Seasoned professional contributor with responsibility for an advanced area of work in the professional field
• May be responsible for entire projects or functions having modest scope/impact or portions of projects having considerable scope/impact to department results

EDUCATION/EXPERIENCE:

• BS degree in Science, biomedical, mechanical, industrial or similar engineering discipline
• 3+ years of Quality Assurance /Engineering experience in an FDA-regulated industry
• Prefer cGMP pharmaceutical industry, biologics industry experience; medical device or tissue processing industries considered
• Prefer Certified Quality Engineer (CQE) or other similar Quality/reliability certifications
• Prefer Six Sigma certification
• Knowledge of FDA, AATB, ISO, and other state/federal/international regulations and standards
• Experience in utilization of statistical techniques such as the design of experiments, hypothesis testing, SPC, etc.

SKILLS/COMPETENCIES:

• Excellent oral, written, and interpersonal communication skills
• Proficient in Microsoft Office (Excel, Word, etc.) and Minitab
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
• Must show aptitude to develop appropriate skills needed for the job