Quality Engineer Process Manager

Position Summary:

The Quality Engineer Process Manager – QC Laboratory is responsible for supporting laboratory instrumentation and computerized systems within a GMP-regulated environment, with a strong focus on data integrity. This role acts as a subject matter expert (SME) and system administrator for instruments and systems used in QC testing, Analytical and Microbiological Analysis (GMA) instruments. The engineer provides technical oversight, manages qualification activities, and ensures regulatory compliance and data reliability throughout system lifecycles.

Essential Duties & Responsibilities:

• Serve as SME and system administrator for QC laboratory instruments and computerized systems, including GMA equipment.


• Ensure all computerized systems are implemented and maintained in compliance with data integrity principles, GMP regulations, and internal policies.


• Manage qualification, validation, and periodic review activities for laboratory instruments and computerized systems.


• Troubleshoot instrumentation/system issues and coordinate resolution with internal teams (IT, Engineering) or external vendors.


• Author and review documentation including SOPs, user requirements, system specifications, and validation protocols.


• Collaborate with IT, Validation, and QC personnel on change controls, deviations, investigations, and CAPAs.


• Serve as key laboratory resource for audit/inspection readiness activities; presenting data integrity and system management processes during regulatory inspections.


• Lead and participate in risk assessments and continuous improvement initiatives to enhance system reliability and compliance.


• Provide training to QC staff on the operation and administration of laboratory computerized systems.


• Maintain current knowledge of regulatory expectations and best practices related to data integrity and computerized system validation.

Secondary Responsibilities and Functions

• Foster effective working relationships with internal and external stakeholders.


• Ensure all laboratory activities are conducted in full compliance with cGMP and applicable quality system requirements.


• Implement and maintain robust data backup and disaster recovery strategies for critical laboratory systems.


• Contribute to regulatory inspection readiness through proactive compliance and documentation practices.


• Ensure continued GxP compliance of QC laboratory computer systems and software.


• Perform additional duties and projects as assigned by management.

Minimum Qualifications:

• Education/Training:


• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field is required. Master’s degree preferred.


• Strong understanding of data integrity principles and ALCOA+.


• Strong understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

Experience:

• Minimum 5 years of experience in a GMP-regulated QC laboratory, preferably within the biopharmaceutical industry.


• Experience managing laboratory systems in a GxP environment.


• Hands-on experience with instrument qualification, computerized system validation, and administration.


• Prior experience supporting QC instrumentation.


• Experience with platforms such as LIMs, MODA, LabX, or equivalent.


• Experience with regulatory submissions (IND/BLA) and GMP inspections is a plus.

Skills:

• Strong verbal and written communication skills.


• Excellent organizational, planning, and time management abilities.


• Proficiency in software systems, data analysis, and project coordination.


• Demonstrated problem-solving and critical thinking skills.


• Ability to manage multiple priorities and meet deadlines in a dynamic environment.


• Ability to work effectively across functional teams and manage stakeholder relationships.


• Demonstrated ability to apply logical reasoning and sound decision-making.


• Expected to stay informed on evolving regulatory guidance for data integrity and computerized systems compliance