Teams at BioPharma Consulting JAD Group

Provides engineering and compliance support for manufacturing automation, equipment, utilities, calibration, maintenance, validation, and system upgrades in a regulated environment. Supports FDA inspections, investigations, audits, SOP and training implementation, environmental monitoring, high-purity water systems, sanitization changes, and continuous improvement initiatives. Collaborates cross-functionally with maintenance and plant engineering teams to ensure system performance and regulatory compliance.

Leads complex engineering, process optimization, troubleshooting, system modifications, experiments, and capital projects across pharmaceutical operations and manufacturing. Develops engineering procedures, technical solutions, budgets, validation documentation, and project schedules while coordinating engineers, technicians, consultants, and cross-functional teams. Requires pharmaceutical process knowledge, GMP/GLP familiarity, validation experience, and the ability to manage multiple projects and regulated manufacturing initiatives.

Provides technical quality assurance expertise in a regulated manufacturing environment. Reviews and approves manufacturing, validation, environmental, and quality documentation; leads investigations, incident triage, change control, audit readiness, and compliance assessments. Owns site quality procedures and collaborates with manufacturing, facilities, utilities, validation, and process development teams. Supports regulatory interactions, data trending, process validation, and new product introduction activities.