Quality Validation Engineer Pharma Onsite Devens

Quality Validation Engineer Pharma (Onsite Devens, MA)

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Reporting Manager and sometimes will interact with departments such as Quality Control, Manufacturing Operations, Manufacturing Engineering, Manufacturing Science and Technology (MS&T), Validation, Site Engineering and Digital Plant.

This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role in Devens, MA.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities:

• Provides Quality Assurance (QA) support to Devens Site and reporting Manager through quality review and approval of Investigations and Corrective Actions.
• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
• Review and approves Standard Operating Procedures (SOPs).
• Review and approval of Validation-related documentation such as risk assessments, protocols, 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 Validations.
• 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:

• 10+ years in the advanced level of relevant experience in a GMP, GCP, or GXP with focus on product quality.
• Experience with Quality, Quality Control, Validation, and Automation related documents
• Experience of QC equipment Qualification and some project management.
• 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.
• Experience with Enterprise Software like Infinity, DeltaV, Syncade, etc.
• Knowledge of Data integrity principles. Comfortable working in an FDA regulated environment.

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