Senior manufacturing engineer

Responsibilities:

• 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.
• 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.

Requirements:

• Knowledge of science generally attained through studies resulting in a B.S; in biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
• Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality. Preferred Active member of ASQ or ISPE.
• Prior experience of QC equipment Qualification and some project management experience.
• 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, Track Wise, Veeva Vault and electronic or paper-based batch records desirable.
• Excellent Technical writing and oral communication skills are required.
• Background in problem solving.
• Knowledge of Data integrity principles.
• Proven attention to details.
• Comfortable working in an FDA regulated environment.
• Quality Control Equipment experience preferred.
• Technical Writer.
• Investigations/Deviation experience preferred.