Sr Engineer

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Develop engineering policies and procedures that affect multiple organizational units.  Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.  Coordinate the work of consultants, architects and engineering firms on development of standard design documents. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Ability to interpret and apply GLPs and GMPs. Comprehensive understanding of validation protocol execution requirements.  In-depth knowledge of validation processes and requirements as applied to new equipment installations. Qualifications:  Bachelor's degree in Engineering Five (5) years of Engineering experience  • Knowledge and experience working with Change Controls on trackwise. (Prefer experience that we are looking) Knowledge in Packaging equipment. Knowledge in Design of new equipment process. Knowledge in Engineering Project  Knowledge in Validations and Commissioning Experience in Medical Device or Pharma Knowledge in CAPA and Compliance Availability for 1rst and 2nd shift  Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR