Requisition Number: P11691
Join our Design Development Team as a VALIDATION ENGINEER, working on medical device products that are in product development, moving to commercialization.
- Strong Understanding of Statistics.
- Proven ability to effectively provide technical information at all levels of the organization and externally with customers.
- Experience in maintaining a Master Site Validation Plan
- Coordinate, direct and lead validation efforts including:
- Computer System Validation including Electronic Records & Electronic Signature Assessments, Risk Assessment, Supplier Assessment
- -Equipment and Instrumentation Qualification
- -Facility and Utility Qualification
- Compile and analyze validation data, write/review/approve protocols, reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files.
- Facilitate and/or support validation training, change control, periodic review of validated systems, equipment, and processes and support change management.
- Functions as a liaison with project engineering, manufacturing and the customer
- Interface with customers on a regular basis to resolve issues
- Extended travel to other facilities may be required to support business needs
- Some programs may have vision requirements
- Other duties as assigned
Qualifications - Education & Experience
- B.S. degree in engineering field with 2+ years of related experience validating equipment and machines used in manufacturing
- Knowledge of manufacturing processes, including injection molding, preferred
- Medical device industry experience preferred
Qualifications - Skills & Competencies
- Strong and diverse validation skills
- Ability to manage multiple large-scale projects
- Demonstrated superior communication, teamwork and organizational skills
- Ability to develop and meet project schedules, along with contingency plans
- Demonstrated ability to think out of the box and recommend options
- Demonstrated broad understanding of capabilities and technologies of other PPC facilities, suppliers, and customers
- Ability to effectively present information and respond to questions from group of managers, sales, and customers
- Strong communication (verbal and written), teamwork and organizational skills
This facility operates under International Traffic in Arms Regulations (ITAR), and therefore, any person hired must demonstrate with verifiable documentation that he/she is either: (i) a U.S. Citizen; (ii) an active Green Card Holder; or (iii) a “Protected Person” as defined by 8 U.S.C. 1324(b)(a)(3).