Pharmaceutical Engineer

Job Description

Introduction
Visium Resources has been asked to identify qualified candidates for this Pharmaceutical Senior CQV Engineer position. This position is a direct hire which is expected to be on-site in Raleigh, NC.

Summary

We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with upstream and downstream GMP-regulated process equipment, utilities, automation systems, clean rooms, and manufacturing operations.

This role requires hands‑on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV 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 CQV activities for pharmaceutical and biotech capital projects.
• Develop and execute:
• • Commissioning plans
  • IQ/OQ/PQ protocols
  • Validation test scripts
  • Traceability matrices
  • Summary reports
• Support startup and qualification of:
• • Process equipment
  • Clean utilities
  • HVAC systems
  • Manufacturing suites
  • Automation and control systems
• Coordinate field execution activities with engineering, construction, vendors, and operations teams.
• Perform system walkdowns and turnover package reviews.
• Support deviation investigations, CAPAs, and change control activities.
• Ensure all validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines.
• Participate in FAT/SAT execution and acceptance activities.
• Support project schedule development and milestone tracking.
• Collaborate with Quality Assurance and Manufacturing teams to support inspection readiness and successful system release.
• Mentor junior CQV engineers and validation specialists as needed.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
• 5-10+ years of CQV, validation, or pharmaceutical 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
  • Clean rooms
  • Automation systems
• Experience authoring and reviewing validation lifecycle documentation.
• Strong technical writing and documentation skills.
• Ability to work independently within fast-paced project environments.

Preferred Qualifications

• Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments.
• Previous consulting experience within life sciences industries preferred.
• Familiarity with:
• • DeltaV
  • MES systems
  • SCADA platforms
  • Kneat or electronic validation systems
• PMP certification or equivalent project leadership experience is a plus.
• 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