Support the Serialization team responsible for the worldwide implementation of Serialization capability. Work closely with the Serialization resources to ensure solutions meets regulatory timelines and deliverable.
Support the Operational Qualification (OQ) and developed associated documentation.
Data and test scripts in support of IQ, OQ, & PQ validation milestones.
Testing in Serialization core system.
Identifies technical issues coming from QA testing.
Develop test scripts, OQ and capturing and preparing documents for review.
Support and assist in the execution of validation strategy and validation master plans.
Contribute to project URS, FS, DS and validation documents.
Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
Other task may be assign.
Bachelor's in Mecchanical Engineering with 7+ years of professional experience.
Knowledge and experience of the integrative solutions for Track & Trace, packaging line equipment and serialization solutions.
Knowledge on computerized systems with data collection software (database), network communications protocols.
MUST demonstrate technical writing documentation skills in English and using MS Office applications bilingual Spanish & English).
Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
Able to multitask.
Available to work non-standard shift if require (weekends, holidays and over time).
Positions available for Puerto Rico.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.