JT349 - 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 engineering preferred
• +4 years of Engineering experience
•  Packaging and Materials Science background is a plus
• Fully Bilingual (English/Spanish)
• Familiar with distribution testing per ASTM D4169, International Organization for Standardization (ISO), Technical Association of the Pulp and Paper Industry (TAPPI), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP)
• Strong knowledge of primary and secondary packaging systems and material science (common materials used in healthcare packaging)
• Material knowledge of structural components is integral in the day-to-day oversight of this role: labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc
• Experience building, modifying, and approving engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications
• Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components
• 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