Quality Engineering Lead - Manufacturing & Validation

Creative Solutions Services, LLC; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Engineering Project Manager to lead a multidisciplinary team responsible for supervising manufacturing quality oversight, validation, and compliance activities. The role requires directing quality engineering efforts across processes, equipment, utilities, and facilities while ensuring adherence to cGMP and regulatory standards.

The successful candidate will guide risk management, support process development and tech transfer, and communicate

Qualifications

• Bachelor's degree required in a physical or life science, pharmacy, or engineering field.
• Candidates should have strong quality engineering knowledge and applicable regulatory awareness (cGMP, etc.).
• Experience leading teams in manufacturing QA/QC/R&D environments is expected.

Responsibilities

• Leads and develops a team of quality engineers supporting manufacturing process quality oversight, validation, qualification, and compliance activities.
• Provides functional leadership for quality engineering activities across manufacturing processes, equipment, utilities, facilities, and associated systems.
• Provides technical direction for quality engineering matters related to base business operations, development, tech transfer, and market expansion projects.
• Ensures validation and qualification strategies, protocols, reports, and lifecycle activities are executed in accordance with Client Quality Systems, cGMP requirements, and applicable regulations.
• Reviews quality and compliance gaps related to manufacturing processes, equipment, utilities, systems, and change controls, and drives appropriate risk-based actions.
• Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to support compliant implementation of new and existing processes.
• Guides risk management activities, including assessments, mitigation planning, and application of quality risk management principles.
• Oversees or supports qualification and validation activities for equipment, processes, cleaning, utilities, computerized systems, and methods, as applicable.
• Ensures quality engineering issues impacting product quality, process robustness, and regulatory compliance are identified, escalated, and resolved.
• Communicates quality engineering status, key risks, trends, and recommendations to management and executive stakeholders, and manages functional resources and budget to support efficient execution.

Skills

Team leadership

Quality systems

Risk assessment

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Physical or Life Sciences, Pharmacy, or Engineering

Master's or PhD in Life Science or Engineering (highly desired)

Job description

Creative Solutions Services, LLC is seeking a Quality Engineering Project Manager to lead a multidisciplinary team responsible for supervising manufacturing quality oversight, validation, and compliance activities. The role requires directing quality engineering efforts across processes, equipment, utilities, and facilities while ensuring adherence to cGMP and regulatory standards.

The successful candidate will guide risk management, support process development and tech transfer, and communicate