The Senior Quality Control Engineer is responsible for leading the implementation, validation, and integration of GMP Quality Control laboratory systems in regulated pharmaceutical or biotechnology environments. This role oversees system configuration, data migration, IQ/OQ/PQ validation, CSV/CSA activities, and regulatory compliance while collaborating with QA, IT, laboratory teams, and vendors. The engineer ensures adherence to GxP, Data Integrity, and GAMP 5 standards, supports system deployment and go-live activities, and drives successful project execution through effective stakeholder management and continuous process improvement.
- 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
- Experience managing system integrations, data migration, and cross-functional project delivery.
- Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.Strong stakeholder management, Agile/Scrum, and project coordination skills.Excellent communication and documentation capabilities
- Bachelor's degree in one of the following fields:
- Chemistry
- Biochemistry
- Biology
- Microbiology
- Pharmaceutical Sciences
- Lead implementation and integration activities for GMP QC systems.
- Coordinate system configuration, data migration, deployment, and stakeholder engagement.
- Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
- Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
- Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.