Sr. Associate Mfg Systems

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc is seeking a Sr. Associate Mfg Systems to provide technical engineering support for system optimization, upgrades, and compliance with FDA and regulatory standards.

Responsibilities include coordinating maintenance team training, SOPs, and standards; assisting during regulatory inspections; supporting audits and engineering improvements; and addressing issues in utility, process, and clean room systems.

Qualifications

• Engineering degree with 2+ years of experience, or Associate’s degree with 6 years of Engineering experience, or High school diploma/GED with 8 years of Engineering experience.

Responsibilities

• Evaluate utility, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems for compliance with industry, regulatory, and FDA standards.
• Ensure the maintenance team training, SOPs and equipment/operational standards are consistent across the team.
• Coordinate technical support to maintenance on engineering, regulatory, compliance, calibration, quality, environmental, validation and process maintenance issues.
• Assist during FDA and other regulatory inspections; provide technical support to the maintenance team.
• Respond to high purity water systems and environmental monitoring alerts; assist investigations.
• Develop and maintain an audit program for the maintenance team and facilitate routine audits.
• Assist plant engineering in evaluating and implementing engineering improvements, policy changes and optimization programs.
• Test proposed sanitization and maintenance procedure changes for process, utility and clean room systems.

Skills

Leadership

Teambuilding

Verbal communication

Written communication

Technical writing

Organization

Facilitation

Change management

Validation protocols

Equipment knowledge

Analytical problem solving

Project management

Scheduling

Computer literacy

Education

Engineering degree requirements

Job description

SUMMARY

In a full automation role the Sr. Associate Mfg Systems will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.

FUNCTIONS

• 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 on 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.

Other functions that may be assigned

EDUCATION/LICENSES

• Master’s degree or Bachelor’s degree and 2 years of Engineering experience or Associate’s degree and 6 years of Engineering experience or High school diploma / GED and 8 years of Engineering experience.

COMPETENCIES/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

Weil Group is proud to be an Equal Employment Opportunity Employer.