The Director of Engineering is primarily responsible for the development and implementation of the validation program and ensuring that assets and processes are appropriately qualified prior to implementation.
This role also oversees the preventative maintenance and calibration of equipment, ensuring on-going compliance.
The Director of Engineering collaborates with laboratory operations and product development to facilitate product design and development activities and actively pursues quality improvement initiatives.
Requirements: Background A minimum of 10 years of direct experience in process validation, process development, technology transfer, technical manufacturing support experience in clinical and/or commercial GMP setting within a pharmaceutical or biotechnology environment.
Prior experience with a successful device submission with experience in process development, design transfer, equipment qualification, and process validation Prior experience supporting commercial operations, product life cycle management, continued process verification (CPV) Full working knowledge of 21 CFR Part 820 and other regulatory guidelines (ICH, WHO, EU, GAMP, etc.) Knowledge of the following systems: Qualification/Validation best practices (IOQ, PQ, PV, CSV, etc.), calibration and equipment tracking systems, building management systems, ERP systems, LIMS system, deviation/CAPA/change control system Accountability/Scope Responsible for setting department objectives and securing resources to meet company strategic goals.
Provides leadership for Quality Engineers through effective communication, coaching, training, and development.
Provides leadership for problem resolution to facilitate fast improvements and improved working relationships.
Develops and implements a culture of continuous improvement through the utilization of self-directed work teams.
Develops and oversees the calibration and preventive maintenance program, ensuring timelines are met.
Develops and oversees asset and process validation programs, ensuring validation timelines are met.
Work with production to be aware of production schedule and needs, ensuring quality engineering is working cross functionally with production to achieve goals.
Establishes, prepares, implements, revises, and maintains policies and procedures related to engineering and facilities.
Ensure adherence to GMP and safety procedures.
Education Bachelor’s degree, in a Biology, Chemistry, or Engineering field.
Advanced degrees or qualifications desirable.
Physical Demands Employee may be required to lift routine office supplies and use standard office equipment.
Ability to sit for extended periods of time.
Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.