JT333 - 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:

• 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 mechanical, electrical or industrial engineering preferred
• +4 years of Engineering experience
• Packaging Process experience.
• Extensive experience in Commissioning & Qualification (C&Q) for GMP-regulated pharmaceutical or biotechnology facilities.
• Proven expertise in developing and executing C&Q strategies, including system risk assessments and qualification planning.
• Strong experience with commissioning activities ( FAT, SAT, startup, and field commissioning).
• Proficient in authoring and executing IQ, OQ, and PQ protocols with full traceability from URS to final qualification.
• Solid knowledge of GMP, FDA, EMA, ASTM E2500, ISPE Baseline Guide, and ALCOA+ data integrity principles.
• Experience managing risk assessments, change controls, deviations, CAPAs, and validation documentation.
• Skilled in cross-functional collaboration with Engineering, QA, Manufacturing, and project stakeholders.
• Experience developing, executing, and reporting process characterization studies.
• Administrative 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.