Engineer Manufacturing Systems
PharmaLex
- Juncos, PR
- Permanent
- Full-time
- Competitive salaries
- Ability to earn additional income based on hours worked (Biweekly basis)
- Free High-Quality webinars provided by experts from around the world
- Committed to keeping our consultants in project continuity
- Referral Program
- Wellness Program
- Recognition Program (for employees only)
- Service Award Program (for employees only)
- Discount Program (for employees only)
- An administrative team that is oriented to providing excellent service that pursues satisfying the needs of our consultants.
- For our projects in the US, we cover travel/lodging/transportation expenses (employees only)
- 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.
- Ensure the maintenance team training program, standard operating procedures, and equipment/system operational standards are consistent throughout the team.
- Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues, and process maintenance issues.
- Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
- Assist the maintenance team when responding to high-purity water systems and environmental monitoring alert/action notifications.
- Assist with the investigation of all alert/action notifications.
- Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations, and related areas to ensure a continued state of compliance
- Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements, and optimization programs.
- Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility, and clean room systems.
- Background in programming, installation of manufacturing process controls, automation, and field instrumentation technologies.
- Working knowledge of pharmaceutical/biotechnology processes.
- Familiarity with validation processes and documentation in a highly regulated environment.
- Strong verbal communication skills in English and Spanish.
- Skills in the following areas: Problem-solving and root cause analysis, basic technical report writing, basic technical presentations, dealing with and managing change, technical (Equipment Specific) Analytical Problem Solving, and Computer Literacy.
- Knowledge of Rockwell Automation Platform and Allen-Bradley PLCs.
- Knowledgeable on Rockwell Automation Factory Talk & ControlLogix PLC Platform.
- Knowledgeable on Rockwell SLC500 PLC family Controllers.
- Knowledgeable on Rockwell Automation FTView SE and FTBatch systems.
- Knowledgeable on DeviceNet technologies.
- Work schedule flexibility to support 24/7 operations.
- Knowledge of a programming language (e.g. VBA, SQL)
- Knowledge of vision system technology
- Knowledge of the serialization process.
- Basic Knowledge of robot or cobot programming.
- Master’s degree or Bachelor’s degree and 2 years of Engineering experience
- Associate’s degree and 6 years of Engineering experience
- High school diploma and 8 years of Engineering experience