Category: Scientific & Clinical
Title: Engineering Project Manager
Location: Pompano Beach, FL
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- Company is seeking a Staff Quality Engineer to provide manufacturing and software quality engineering expertise for product manufacture, raw material quality, validation, product-related projects and investigations in a biological product manufacturing facility.
- This position is also responsible for approval and review of manufacturing non-conformances while keeping into perspective the safety and efficacy of the products and business impact.
- Provides manufacturing and software quality engineering expertise to projects teams in compliance with FDA, ISO and CMDR regulations and Quality System Requirements.
- Responsible for application of Root Cause Investigation Process and Procedures.
- Demonstrates Technical Writing Skills (Quality Records, technical memorandums, procedures, protocols and reports.)
- Demonstrates thorough knowledge and application of validation regulations and guidance documents, principles, techniques and procedures.
- Performs other duties as assigned.
- A minimum of a Bachelor’s degree with a minimum of 7 years of experience at a medical or manufacturing facility; or equivalent combination of education and experience.
- Background/experience with application of software quality engineering principles in biological product manufacturing is highly desirable.
- Must be able to apply quality engineering critical thinking to the manufacture of biological products and manufacturing environment.
- Must be able to synthesize complex ideas for effective problem solving.
- Must be able to rapidly acquire and maintain in-depth product knowledge.
- Excellent written/verbal communication and computer skills are essential.
- Candidate should be familiar with regulations and guidelines of all applicable Regulatory agencies, such as FDA (QSR/cGMP), OSHA, ISO (including ISO14001), and Health, Safety and Industrial Hygiene.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.