Sterilization Validations Project Manager
Act as a study director for industrial sterilization validations of medical devices from study development through completion.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The responsibilities with respect to the planning of tests and evaluation of results:
- Interface with the laboratory, sterilization personnel, and customers to determine sterilization needs
- Evaluate testing requirements for validation
- Prepare quotations for validation studies
- Write, review, and approve protocols
- Provide direction during the conduct of validation studies
The responsibilities for reporting opinions and interpretations:
- Understand and interpret sterilization standards
- Write, review, and approve final reports
- Evaluate out of specification conditions in the sterilization processes
- Advance skills through trade organization seminars or meetings
- Understand the sterilization process and equipment
- Interface with customer during technical visits and audits as needed
- Write, review, and approve work instructions
- All other tasks as assigned by management
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE
BS or higher in a science or engineering related field
Expertise and Experience Required
- Sterilization standards and process validation knowledge
- 4-6 years of medical device experience
Qualifications and training program – the following training programs, certifications, and qualifications are beneficial:
- ISO Training/experience
- GMP Training
- AAMI Industrial Sterilization courses
- Project Management Training
Strong computer skills, including experience with Microsoft word processing and spreadsheet programs.
Must have proofreading, spelling, grammar, and technical writing skills. Must have the ability to communicate effectively with customers or employees of the organization.
Ability to perform the calculations used in manipulating data.
Ability to analyze data and reach a conclusion, read, interpret, and relay requirements for testing to other employees.
OTHER SKILLS and ABILITIES
Project management, good organization, time management, reading, writing, proofreading and editing skills. Read, understand and interpret sterilization standards.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit, stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear.
The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close, color, and peripheral vision and the ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Combination of office and warehouse/industrial setting with regular potential for exposure to fumes or airborne particles, toxic or caustic chemicals, working near moving mechanical parts, working in some precarious places, outdoor weather conditions and with some risk of electrical shock. Moderate to loud noise levels exist.
iuvo Bioscience is an Equal Opportunity Employer.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.