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:
- Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment
- 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
- Develop engineering policies and procedures that affect multiple organizational units.
- Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
- Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Qualifications:
- Bachelor’s degree in Engineering Required
- Packaging Process Experience
- Fully Bilingual (English/Spanish)
- 5+ years of experience in Commissioning, Qualification, and Validation within the pharmaceutical, biotechnology, or medical device industry.
- Hands-on experience leading and executing:
- FAT/SAT activities
- Commissioning activities
- IQ/OQ/PQ protocols
- Characterization studies
- Experience supporting greenfield and/or brownfield projects.
- Experience with GMP direct impact and indirect impact systems.
- Knowledge of Change Control, Deviations, and CAPA processes.
- Strong technical writing, project management, communication, and cross-functional collaboration skills.
- Administrative Shift but it is important for the candidate to remain flexible, as there may be occasions when support is needed for non-standard shifts based on manufacturing line production demands
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.
