Requisition Number: P11691
We are seeking an experienced VALIDATION ENGINEER, to work on validating the manufacturing processes, equipment and facilities, and maintaining the Master Site Validation Plan, used in medical device products that are in product development at our Design Development Center.
Coordinate, direct and lead validation efforts of:
- Process - molding, assembly, manufacturing including secondary operations
- Equipment and Instrumentation qualification
- Facility and Utility qualification
- Risk Assessment, Supplier Assessment, and Electronic Records and Electronic Signature Assessments
- Compile and analyze 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 systems, equipment, and processes and support change management.
- Work closely with project engineering, manufacturing and the customer
- Proven ability to effectively provide technical information at all levels of the organization and externally with customers.
- 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/drug delivery device manufacturing industry experience
- Experience in maintaining a Master Site Validation Plan
Qualifications - Skills & Competencies
- Strong and diverse validation skills
- Strong Understanding of Statistics.
- 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).