What are the responsibilities and job description for the Facilities / Validation Engineer position at BEPC Inc. - Business Excellence Professional Consulting?
Facilities / Validation Engineer
Job Summary:
We are seeking an experienced Facilities / Validation Engineer with a strong background in validation principles, equipment qualification, and facilities management within the medical device industry. This role is responsible for ensuring compliance with requirements, for equipment installation and validation, overseeing facility improvements, and optimizing equipment reliability.
The ideal candidate will have expertise in IQ, OQ, and process development protocols, facility engineering, and regulatory compliance in a GMP environment.
K
ey Responsibilities:
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Lead the installation of new equipment and execute Installation Qualification (IQ), Operational Qualification (OQ), and other Qualification protocols for facilities equipment, processes, and systems in a medical device manufacturing environment.·
Develop and implement Master Validation Plans (MVPs) in accordance with FDA, ISO 13485, and GMP requirements.·
Develop project timelines, schedules, and resource plans, ensuring timely execution of validation projects.·
Ensure compliance with industry regulations, conducting root cause analysis and corrective actions for validation deviations.·
Generate validation documentation (protocols, reports, risk assessments, and SOPs).·
Conduct re-validation as needed due to engineering changes, deviations, or system upgrades.·
Plan and execute facility upgrades, and repairs to ensure compliance with regulations.·
Develop and implement preventive maintenance procedures for facility equipment.·
Conduct safety inspections and ensure compliance with EHS regulations.·
Work with contractors, engineers, and vendors to manage installation of equipment.·
Participate in cross-functional team meetings to align facility and validation strategies with business objectives. E
d
ucation & Experience: ·
Bachelor’s degree in engineering, Facilities Management, or a related field.·
5 years of experience in validation engineering, facility management, or project management within a medical device, or regulated manufacturing environment.· E
xpertise in validation principles, process development, and statistical process controls.· E
xperienced in Air Conditioning units, water coolers, heaters, heater pumps, hydraulics, humidity and temperature recording devices, manufacturing equipment, etc.· P
roficiency in MS Word, MS Excel, MS Project, and AutoCAD· F
amiliarity with J&J validation methodologies and change management systems is a plus.
