Quality Engineer - Process Validation & PPQ Support

Collabera; Worcester (MA); On-site; USD 75,768 - 82,656; Part time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid vacation time

Paid parental leave

Paid sick leave

Job summary

A leading quality assurance firm is seeking a Quality Engineer - Process Validation in Worcester, Massachusetts. The successful candidate will ensure quality standards in the manufacturing of pharmaceutical products and biologics, supporting processes like qualification and compliance. Ideal candidates should have at least 5 years of experience in manufacturing or quality control with a focus on biologics. The role offers competitive pay and benefits.

Qualifications

• Minimum 5 years of experience required.
• Ideal candidates should have biologics and tissue handling experience.
• Experience with method and equipment validation is applicable.

Responsibilities

• Support new product introduction for pharmaceutical and medical products.
• Oversee quality of biologics manufacturing.
• Create and manage qualification campaigns for drug substance processes.

Skills

Manufacturing or quality control experience

Document review

Validation Documents experience

Familiarity with biologics manufacturing

Tools

TrackWise

Veeva

SAP

Oracle

Job description

A leading quality assurance firm is seeking a Quality Engineer - Process Validation in Worcester, Massachusetts. The successful candidate will ensure quality standards in the manufacturing of pharmaceutical products and biologics, supporting processes like qualification and compliance. Ideal candidates should have at least 5 years of experience in manufacturing or quality control with a focus on biologics. The role offers competitive pay and benefits.