PharmaLex
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Associate Tech Engineering
role at
PharmaLex .
Summary of Role The Associate Technical Engineering 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 current corporate policies, industry standards, regulatory standards, and FDA standards.
Responsibilities
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 with pneumatics, automatic control and vision inspection systems required.
Identify and resolve all problems related to process equipment and, where possible, minimize equipment downtime. Complete advanced maintenance activities, including but not limited to preventive maintenance and other maintenance tasks.
Monitor inspection and packaging equipment, with the ability to investigate and troubleshoot advanced issues or problems including mechanical, electrical, or automation.
Assist the team with maintaining an up-to-date working spare parts inventory system.
Ensure that operational log paperwork, daily log files, and work order documentation is completed with accurate information.
All work must be guided by team requirements or department objectives and completed in accordance with CFRs, cGMPs, SOPs, job plans and policies.
Develop, revise, and review SOPs or job plans/work plans for work-related areas.
Evaluate current maintenance procedures and assist in changes to optimize the maintenance program.
Recognize and report malfunctions and adjust equipment.
Provide technical expertise and act as a resource/trainer to others on maintenance support tasks and/or in the use of all the equipment used in the area.
Provide customer service to internal and external clients, including ongoing support with detailed technical information and solving technical situations.
Skills
Leadership and team building
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
Job Details
Shift:
Non-Standard Shift - 12 hours shift
Location:
Juncos, PR
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.
Contract Type:
Fixed-term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state or local law. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. Messages and emails regarding anything other than accommodation requests will not be returned.
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Associate Tech Engineering
role at
PharmaLex .
Summary of Role The Associate Technical Engineering 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 current corporate policies, industry standards, regulatory standards, and FDA standards.
Responsibilities
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 with pneumatics, automatic control and vision inspection systems required.
Identify and resolve all problems related to process equipment and, where possible, minimize equipment downtime. Complete advanced maintenance activities, including but not limited to preventive maintenance and other maintenance tasks.
Monitor inspection and packaging equipment, with the ability to investigate and troubleshoot advanced issues or problems including mechanical, electrical, or automation.
Assist the team with maintaining an up-to-date working spare parts inventory system.
Ensure that operational log paperwork, daily log files, and work order documentation is completed with accurate information.
All work must be guided by team requirements or department objectives and completed in accordance with CFRs, cGMPs, SOPs, job plans and policies.
Develop, revise, and review SOPs or job plans/work plans for work-related areas.
Evaluate current maintenance procedures and assist in changes to optimize the maintenance program.
Recognize and report malfunctions and adjust equipment.
Provide technical expertise and act as a resource/trainer to others on maintenance support tasks and/or in the use of all the equipment used in the area.
Provide customer service to internal and external clients, including ongoing support with detailed technical information and solving technical situations.
Skills
Leadership and team building
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
Job Details
Shift:
Non-Standard Shift - 12 hours shift
Location:
Juncos, PR
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.
Contract Type:
Fixed-term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state or local law. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. Messages and emails regarding anything other than accommodation requests will not be returned.
#J-18808-Ljbffr