Job Description

Deviation Investigation Support – Operations

Location: On-site in Concord, NC

Engagement Type: 6–12 month contract (with potential for extension)

Company: Brooksource Engineering Services

Client: Pharmaceutical Manufacturing Partner

Position Overview

Brooksource Engineering Services is seeking a Deviation Investigator to support our pharmaceutical manufacturing client in Concord, NC. This is a contract role (6–12 months) with the potential for extension, ideal for professionals with 3–5 years of experience in technical writing, root cause analysis, and quality engineering.

This role focuses on writing deviations for a production line that is not yet commercially approved. The position begins with extensive training and study of existing lines, with deviations expected to gradually increase. This is a capacity-driven role and a great opportunity to contribute to a growing operation.

Key Responsibilities

• Conduct thorough investigations into deviations, identifying root causes and contributing factors using engineering-based RCA methodologies.
• Write clear, concise, and technically sound deviation reports.
• Collaborate with cross-functional teams to gather information and ensure timely resolution of deviations.
• Apply critical thinking and technical knowledge to recommend effective corrective and preventive actions (CAPAs).
• Ensure compliance with internal procedures and regulatory standards.

Requirements

• 3–5 years of experience in a technical or quality-focused role.
• Strong technical writing skills, with the ability to clearly explain complex issues.
• Experience with root cause analysis (RCA), preferably in an engineering discipline.
• Proficiency in Microsoft Office Suite or similar tools.
• Excellent communication and analytical skills.
• Ability to work independently and manage shifting priorities.

Preferred Qualifications

• Background in engineering, life sciences, or quality engineering (preferred over quality assurance).
• Experience in pharmaceutical or biotech manufacturing environments.
• Familiarity with deviation management systems and CAPA processes.

Additional Information

• Shift: Regular business hours (8:00 AM – 5:00 PM).
• Training: Extensive onboarding and training provided.
• Workload: Initial phase will be training-heavy with deviations expected to increase over time.
• Candidates without direct pharma or manufacturing experience are encouraged to apply if they meet the core requirements.

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