Lead CQV Engineer (Upstream Manufacturing) / Lead Project Engineer

LVI Associates; Holly Springs (NC); On-site; USD 107,000 - 178,000; Full time

Job summary

An established industry player is seeking a Lead CQV Engineer to oversee commissioning, qualification, and validation activities in a state-of-the-art drug product facility. This role demands a seasoned professional with over a decade of experience in CQV within GMP environments, particularly in upstream manufacturing processes. You will lead a team to ensure compliance with CQV standards, develop protocols, and coordinate with various departments. This is a fantastic opportunity to contribute to groundbreaking projects in the life sciences sector, where your expertise will play a crucial role in delivering high-quality products.

Benefits

Competitive salary with performance incentives

Comprehensive medical, dental, vision insurance

Disability insurance

401(k) with matching

PTO and holiday pay

Employee recognition

Parental leave

Supplemental insurance

Qualifications

• 10+ years of CQV experience in GMP environments.
• Strong background in upstream system validation in biotech or pharma.
• Experience in authoring and executing protocols like FAT, SAT, IOQ, CSV.

Responsibilities

• Lead and manage all CQV activities for upstream manufacturing systems.
• Oversee commissioning, qualification, and validation of bioreactors and centrifuges.
• Develop and execute FAT, SAT, IOQ, and CSV protocols for GMP equipment.

Skills

CQV (Commissioning, Qualification, and Validation)

GMP environments

Technical documentation

Communication skills

Detail-oriented

Tools

Microsoft Word

Excel

PowerPoint

Job description

Lead CQV Engineer (Upstream Manufacturing) / Lead Project Engineer

This role is for a seasoned CQV (Commissioning, Qualification, and Validation) Lead in the life sciences industry, focusing on upstream manufacturing processes at a new greenfield drug product facility. The position involves overseeing activities for equipment such as bioreactors and centrifuges, ensuring full CQV delivery from inoculation through harvest.

Key Responsibilities:

• Lead and manage all CQV activities for upstream manufacturing systems.
• Oversee commissioning, qualification, and validation of bioreactors (single-use and stainless steel) and centrifuges.
• Ensure compliance with CQV standards across all systems.
• Develop and execute FAT, SAT, IOQ, and CSV protocols for GMP equipment.
• Coordinate with departments to facilitate CQV procedures and documentation.

Required Qualifications:

• 10+ years of CQV experience in GMP environments.
• Strong background in upstream system validation in biotech or pharma.
• Experience in authoring and executing protocols like FAT, SAT, IOQ, CSV.
• Knowledge of GMP and GDP practices.
• Proficiency in technical documentation using Microsoft Word.
• Basic skills in Excel and PowerPoint for reporting.
• Excellent communication skills.
• Detail-oriented with good organizational skills.

Position Details:

This is an onsite role at the designated location.

Salary Range: $107,800 to $177,093 USD, dependent on experience and qualifications.

Benefits:

• Competitive salary with performance incentives.
• Comprehensive medical, dental, vision insurance.
• Disability insurance, HSA, FSA, 401(k) with matching.
• PTO, holiday pay, employee recognition, parental leave, supplemental insurance.