Commissioning Engineer

3 weeks ago


Boston, United States Premier Life Sciences LLC Full time

Role: Process Validation Engineer - Pharma

Location: MA

Duration: 12 Months on W2 - No C2C



Conduct quality assurance responsibilities on the production floor, which include reviewing batch records during production, conducting quality walkthroughs, ensuring line clearance, and performing inspections of in-process and final products.

Examine and authorize GMP (Good Manufacturing Practices) documentation against SOPs to ensure accurate recording of manufacturing processes, clarity of observations, and adherence to Good Documentation Practices.

Perform audits and walkthroughs of GMP areas to identify non-compliance issues, inspection risks, and deviations from procedures or GMP standards. Gather and analyze objective evidence to assess risks and their severity.

Represent QA in meetings and project teams, making authoritative decisions and commitments on behalf of QA, and escalating issues to department leadership as needed.

Collaborate closely with Manufacturing Operations to meet production schedules and address operational challenges.

Oversee the management of process control data using standard control charts.

Review and approve the timely closure of Quality Systems items such as Change Controls, CAPAs (Corrective and Preventive Actions), Deviations, Non-Conforming Materials, gap analyses, and product complaints.



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