Associate Tech Engineering

mîrus Consulting Group

Juncos, PR
Permanent
Full-time

19 days ago

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.Job Description

Will 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.
Other functions that may be assigned

Preferred Qualifications

Experience in Packaging Equipment such Thernoformer, Cartoner, Case Packer, Labeler, assembled equipment, Vision System, Serialization, Sensors, Cobots, Mechanical Adjustment, Motor replacement, VFD, PM, Train Tool, PLC Back Up, Pneumatic, Electrical / Mechanical Trouble shooting.

Education

Bachelor's degree or Associate's degree and 4 years of directly related experience or High school diploma / GED and 6 years of directly related experience.

Skills

Leadership and teambuilding
Verbal communication
Written Communication/Technical Writing
Organization
Facilitation
Dealing with and managing change
Comprehensive understanding of validation protocol requirements.
Technical (Equipment Specific)
Analytical Problem Solving
Project Management & Planning
Scheduling
Computer Literacy

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

mîrus Consulting Group

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