What are the responsibilities and job description for the Quality Engineer position at Brooksource?
Job Title: Engineering Deviation Investigator (GMP Sterile Injectable Manufacturing)
Location: Kenosha, WI (Onsite)
Duration: 3‑month contract
Start Date: ASAP
Openings: 2
Company: Brooksource Engineering Services
Position Overview
Brooksource Engineering Services is seeking two Engineering Deviation Investigation resources to support a GMP‑regulated sterile injectable manufacturing site in Kenosha, Wisconsin. These engineers will play a critical role in the site’s quality system by leading and authoring technical investigations, supporting deviation review boards, and driving corrective and preventive actions within a regulated manufacturing environment.
This is a short‑term, high‑impact engagement requiring immediate onboarding and hands‑on experience in deviation investigation and electronic quality management systems.
Key Responsibilities
- Author and manage technical investigations for deviations using formal root cause analysis tools (e.g., 5‑Why, 6M, Fishbone).
- Collaborate closely with site subject matter experts to gather data, technical information, and facts to support investigations.
- Execute investigation records directly within an electronic Quality Management System (Veeva QMS or comparable system).
- Prepare and present investigation summaries for Moderate and Major deviations at Deviation Review Board meetings.
- Partner with site SMEs to define, open, and document CAPAs within the QMS.
- Support CAPA implementation activities, including coordination of document updates, routing approvals, and status tracking within Veeva (as time allows).
Minimum Qualifications
- Engineering background (e.g., Chemical, Mechanical, Industrial, Bioengineering, or similar).
- Minimum of 3 years of experience in a regulated manufacturing environment such as pharmaceutical (injectables preferred), medical device, topical products, food, or cosmetics.
- Strong working knowledge of GMP, GDP, and 21 CFR Parts 210 and 211.
- Minimum of 1 year of hands‑on deviation investigation writing experience.
- Direct experience working in Veeva QMS or a comparable electronic quality management system.
- Ability to work onsite in a sterile manufacturing environment.
- Strong technical writing skills and the ability to synthesize complex information clearly and concisely.
Nice to Have
- Experience supporting sterile injectable manufacturing or aseptic processing environments.
- Prior participation in Deviation Review Boards or similar quality governance forums.
- Exposure to CAPA effectiveness checks and closure activities.
Salary : $40 - $45