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Quality Engineer - Process Validation

Contract: Worcester, Massachusetts, US

Salary Range: 55.00 - 60.00 | Per Hour

Job Code: 364245

End Date: 2025-09-04 Days Left: 29 days, 8 hours left

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Summary: The Quality Engineer is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include the Product QA, Manufacturing QA, Supplier/Incoming QA, Process Qualification/Validation, Compendia management and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with local, Corporate, and governmental regulations. Particular focus on process qualification Process Performance Qualification (PPQ) support and review activities on range of topics from process controls to raw material controls. Responsibilities: Support new product introduction for pharmaceutical products, medical devices, or combination products. Overseeing quality of manufacturing of biologics. Will go through qualification campaign and create qualification campaigns for drug substance manufacturing process. 2 or more products moving through PPQ process by next year. Products are biologics. Role is working with managers with PQA team. Ensuring that ready to start qualification process and ready for filing. Working with managers on process control documents. Must Haves: Bachelors required. Minimum 5 year of exp. Manufacturing or quality control experience. Document review and ensuring alignment in document; QA/QC background. An ideal candidate will have a biologics experience. Tissue handling background will be considered. Top skills: Experience with Validation Documents. Method and equipment validation also applicable. Familiarity with biologics manufacturing Some experience with Document review and associated skills. Plusses: TrackWise, Veeva would be a plus. Some work with ERP, so any experience with SAP, Oracle, ERP would be a plus as they may work on inventory control. Pay Range: $55-60/Hr Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable) Job Requirement Quality Assurance (QA) Quality Control (QC) Biologics Manufacturing Pharmaceutical Manufacturing Medical Devices Combination Products GMP (Good Manufacturing Practices) cGMP Compliance FDA Regulations ICH Guidelines Regulatory Compliance Product Quality Assurance (PQA) Manufacturing QA Process Qualification (PQ) Process Performance Qualification (PPQ) Process Validation Equipment Validation Method Validation Cleaning Validation New Product Introduction (NPI) Technology Transfer Raw Material Controls In-process Controls (IPC) Batch Record Review Deviation Management Change Control Document Review Document Control Validation Protocols (IQ/OQ/PQ) Standard Operating Procedures (SOPs) Quality Documentation Filing Readiness Regulatory Filing Support Audit Support TrackWise Veeva Vault QMS SAP Oracle ERP LIMS (Laboratory Information Management System) Quality Management System (QMS). Reach Out to a Recruiter Recruiter Email Phone Sanjay Rawat sanjay.rawat@collabera.com

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