Quality Validation Engineer Pharma (Onsite Devens, MA)

We are seeking a Quality Validation Engineer Pharma (Onsite Devens, MA) for a global pharmaceutical company. You will be responsible for providing Quality Assurance (QA) support to the reporting Manager through quality review and approval of Investigations and Corrective Actions. You will be interacting with
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.

• Preferred Active member of ASQ or ISPE.

• 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.

Please submit your resume to our network at (please apply to the Quality Validation Engineer Pharma (Onsite Devens, MA) Pharma (Onsite Devens, MA) role).