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: Provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
Provide solutions to a variety of technical problems of moderate scope and complexity Under general supervision will evaluate, select and apply standard engineering techniques and procedures.
Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Function as a technical expert to equipment or systems regarding troubleshooting operations.
Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
Routinely monitor manufacturing processes for performance indicators and operations.
Suggest problem resolution and provide troubleshooting guidance.
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects and engineering firms on development of standard design documents.
Qualifications: Bachelor's degree in engineering field (Mechanical, Industrial and/or Chemical) background Two (2) years of Engineering experience, preferably within packaging operations 5 years general packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.).
Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards.
Strong interpersonal, project management, technical problem solving and communication (written and verbal) skills.
Ability to work in teams and adapt to a continuously evolving environment.
Ability and 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: 8am a 5pm 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.
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