Senior Validation Engineer Lutonix

Department: Quality Assurance/Engineering
Supervisor: Director of Quality
Position Summary:

This exciting and challenging position will be responsible for supporting the validation activities within a dynamic combination medical device / pharmaceutical manufacturing facility. In addition, the position will be required to provide quality engineering leadership on multiple cross functional project teams. The Sr. Validation Engineer will be responsible for providing input and critical review and approval of all validation activities at Lutonix. This will include, but not limited to, Process Validation, Cleaning Validation, Equipment Validation, Utilities Validation, and Facilities Validation activities. Responsibilities will include reviewing, executing and summarizing protocols for processing equipment, laboratory equipment, facility systems, control systems, process and cleaning validation for the production of combination medical device/drug products. Other responsibilities include performing quality and risk management.
Responsibilities:

Use quality engineering techniques to ensure products released for distribution meet their intended performance requirements for safety and efficacy.

Data collection, data interpretation and analysis, root cause analysis and report writing.

Use computer models to determine the safest and most cost-effective production methods.

Assist in the design, analysis and approval of IQ, OQ, PQ, and PV protocols and reports.

Communicate and teach validation approach and requirements.

Maintain master validation plans.

Assess proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.

Participate and provide assistance and technical support on technical project teams as subject matter expert on process validation regulations/procedures.

Support technology transfer of processes.

Critically review and provide support for validation sections of regulatory submissions.

Work closely with Regulatory, Operations and R&D Departments.

Quality and risk management.

Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.

Work on significant problems of diverse scope in which analysis of situations or data requires an in-depth evaluation of variables.

Provide quality engineering support in supplier quality assessments and issues.
Qualifications:

B.S. or M.S. in Engineering, (Preferably Chemical or Mechanical).

8 + years of Quality, Process Development, Process Validation, or Manufacturing engineering experience in the medical device and/or pharmaceutical industry.

Experience with combination products and coating technology preferred.

Ability to troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications, capital projects, and technology transfer.

Ability to function in a fast-paced, highly technical environment.

Strong problem-solving and critical thinking skills.

Sound understanding of engineering and/or chemistry principles and their creative application on-the-job.

Strong mechanical aptitude.

Thorough knowledge of chemical or industrial process design and engineering techniques.

Ability to understand and follow machine drawings, blueprints, and process diagrams.

Computer skills required, with strong proficiency in Microsoft Office software. Skill with CHEMCAD, AutoCAD, and/or Visio is desirable.

Excellent communication skills.

Excellent organizational skills with ability to prioritize and work effectively on multiple tasks.

Ability to work independently (or with minimum supervision),efficiently and be results oriented.

Solid Mentoring skills in developing less experienced engineers.

Ability to perform basic statistical analyses and design experiments.

Experience with Minitab, JMP, or other statistical software packages preferred.

In depth knowledge of Good Manufacturing Practices GMP, Quality System Regulations and ISO quality standards.

While performing duties of this job, would occasionally be required to stand, walk, sit, reach with hands and arms, climb or balance, stoop or kneel, talk and hear, and use fingers and hands to feel objects, tools or controls.

Must occasionally lift and/or move up to 50 pounds.

Non-Standard schedules may be necessary as workloads dictate. This may include after hours work, weekdays, weekends and/or holidays

ASQC certification preferred, not required.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Location:	7351 Kirkwood Lane North Suite 138 Minneapolis, MN 55369 United States