C&Q Engineer

Introduction
Visium Resources has been asked to identify qualified candidates for this Pharmaceutical C&Q Engineer position focused on packaging. This position is a direct hire which is expected to be on-site in New Albany, OH. This position is for the second shift.

Summary

We are seeking a highly motivated C&Q Engineer to support working on packaging equipment & device assembly equipment C&Q in our customers manufacturing facilities.

This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The C&Q Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.

Key Responsibilities

• Lead and execute C&Q activities for pharmaceutical and biotech capital projects.
• Prior packaging equipment C&Q experience is required.
• • device assembly C&Q experience is not required, but an asset
  • environmental rooms (i.e. incubators, cold rooms, freezers, etc..) C&Q experience is not required, but an asset
  • Kneat paperless validation experience is not required, but an asset
• Ability to write & execute C&Q documents
• Close deviations, troubleshoot, communicate with customer, vendors, etc...
• Track issues, close issues

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
• 5-10+ years of C&Q engineering experience within GMP-regulated environments.
• Strong knowledge of:
• • cGMP regulations
  • FDA validation requirements
  • ISPE Baseline Guides
  • GAMP 5 principles
• Experience executing commissioning and qualification for:
• • Process equipment
  • Utilities
  • HVAC systems
  • Cleanrooms
  • Automation systems
• Experience authoring and reviewing validation lifecycle documentation.
• Strong technical writing and documentation skills.
• Ability to work independently within fast-paced project environments.
• Strong client-facing communication and leadership skills.

Additional Skills & Competencies

• Excellent organizational and multitasking abilities
• Strong problem-solving and analytical skills
• Ability to manage multiple priorities and deadlines
• Comfortable working in both office and field environments
• Ability to travel to client sites as required