Quality Associate, Commissioning & Validation

Quality Associate, Commissioning & Validation

Holly Springs, North Carolina, United States

COMPANY

DESCRIPTION:

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with Bio Space's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

We are seeking a Quality Associate, Commissioning & Validation (Mid to Junior level) to support the commissioning and validation of a manufacturing facility. This role is responsible for reviewing, verifying, and documenting that equipment and systems are commissioned, qualified, and validated in alignment with GMP expectations. You will work closely with engineering and technical teams to ensure activities remain compliant, complete, and on schedule.

This is a hands‑on quality role requiring strong attention to detail and the confidence to identify gaps and advocate for corrective actions when needed.

On‑site presence at manufacturing or project locations is required during active commissioning activities.

Commissioning and Qualification

• Review commissioning, IQ, OQ, and PQ protocols and reports for GMP equipment and systems
• Verify execution aligns with approved protocols and regulatory expectations
• Ensure deviations, discrepancies, and punch list items are documented and resolved
• Confirm traceability from requirements through execution and final approval

Quality Oversight

• Provide quality review and approval of validation deliverables
• Ensure documentation meets data integrity and GMP standards
• Support risk assessments, impact assessments, and change controls tied to commissioning activities
• Escalate compliance risks clearly and early

Cross‑Functional Collaboration

• Work directly with engineering, automation, facilities, and manufacturing teams
• Support technical teams by clarifying quality expectations and documentation needs
• Help teams close gaps without unnecessary delays

Schedule and Readiness Support

• Track review timelines and follow up to maintain progress
• Support inspection readiness related to commissioning and validation activities
• Assist with responses to internal or external audit questions

Education

• Bachelor’s degree in science, engineering, or a related field

Technical Experience

• 2 to 5 years of experience in GMP manufacturing, quality, validation, or commissioning support
• Working knowledge of equipment qualification and validation lifecycle
• Familiarity with GMP documentation standards and regulatory expectations

Preferred Experience

• Experience supporting facility start‑ups, expansions, or tech transfers
• Exposure to commissioning and qualification of manufacturing equipment or…