Quality Engineer - Process Validation

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

Overview

Join to apply for the Quality Engineer - Process Validation role at Collabera

This range is provided by Collabera. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$55.00/hr - $60.00/hr

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

• 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.
• 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
• 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)

Seniority level

• Entry level

Employment type

• Contract

Job function

• Quality Assurance