Validation Engineer

• Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.• Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations• Reviews and approves Quality, Quality Control, Validation and Automation related documents• Review and approves Standard Operating Procedures (SOPs).• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.Greater than 12 years of relevant experience in a GMP, Google Cloud Platform, or GXP with at least 10 years focused on product quality. Preferred Active member of ASQ or ISPE.• Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment• Able to interpret complicated data and make sound decisions, Independently