Quality Associate, Commissioning & Validation

Overview

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 organizations from the most critical phases of the drug discovery and approval process through to commercialization.

Syner-G was honored with Bio Space's Best Places to Work 2026 award for the third consecutive year, reflecting our commitment to 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. For more information, visit

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.

Work Location: On-site presence at manufacturing or project locations is required during active commissioning activities.

Key Responsibilities

• 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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 utilities
• Understanding of FDA, EMA, and ICH GMP expectations
• Experience working in fast-paced, cross-functional project teams

Skills and Attributes

• Detail-oriented with strong documentation discipline
• Comfortable working with technical and engineering teams
• Able to manage multiple reviews simultaneously
• Clear communicator capable of raising issues constructively
• Practical mindset focused on compliance and execution

Essential Functions

Physical Demands
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The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable…