Job Description

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 dynamic, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Provide automation support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that supported areas and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.
• Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
• Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
• Assist during FDA and other regulatory agency inspections.
• Provide TECHSUPPORT in response to the FDA and other regulatory agencies.
• Assist in the evaluation and implementation of engineering improvements, policy changes, compliance Improvements and optimization programs.
• Monitor inspection and packaging equipment, with ability to investigate and troubleshoot advance issues or problems including mechanical, electrical, or automation.
• Assist the team with maintaining an up-to-date working spare parts inventory system.
• Develop, revise, and review SOPs or job plans/work plans for work related areas.
• Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program.
• Provides customer service to internal and external clients including ongoing support with detailed technical information and solving technical situations.

Qualifications:

• Bachelor's degree or Associate's degree in related area
• 2 to 4 years of directly related experience
• Experience with pneumatics, automatic control and vision inspection systems required.
• All work must be guided by team requirements or department objectives and completed in accordance with CFRs, cGMPs, SOPs, job plans and client's policies.
• Non-Standard 12-hour shifts

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.