Pharmaceutical Engineer

Visium Resources, Inc.; North Carolina; On-site; USD 120,000 - 170,000; Full time

Job summary

Visium Resources, Inc. in Raleigh, NC is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for pharma and biotech facilities on-site.

You will develop IQ/OQ/PQ protocols, validation scripts, and summary reports while coordinating with engineering, QA, manufacturing, and external vendors. The role requires 5–10+ years of CQV/validation experience in GMP environments, strong knowledge of cGMP, FDA validation, ISPE, and GAMP 5, and the ability to mentor

Qualifications

• Bachelor-level engineering or life sciences degree required with GMP exposure.
• 5–10+ years in CQV/validation within GMP environments.
• Solid knowledge of cGMP, FDA validation, ISPE Baseline Guides, and GAMP 5.
• Experience writing and reviewing validation lifecycle documentation.
• Ability to lead cross-functional teams and document results clearly.

Responsibilities

• Lead CQV activities for pharma/biotech capital projects in a fast-paced setting.
• Develop and execute commissioning plans, IQ/OQ/PQ protocols, and validation scripts.
• Coordinate field execution with engineering, vendors, and operations.
• Ensure validation docs align with cGMP, FDA, ISPE, and GAMP guidelines.
• Mentor junior CQV engineers and contribute to inspection readiness.

Skills

CQV

Validation

Technical writing

Project coordination

GMP compliance

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline

Tools

DeltaV

MES

SCADA

Kneat

Job description

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, cleanrooms, 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-pace 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
  • Cleanrooms
  • Automation systems
• Experience authoring and reviewing validation lifecycle documentation.
• Strong technical writing and documentation skills.
• Ability to work independently within fast-pace project environments.

Preferred Qualifications

• Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments.
• Previous consulting experience within life sciences industries preferred.li>
• 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

Company Description

Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company’s success is based on your success. When you work with us, you are never “just a number”. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the