Description:
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Facility Design Support: Assist in the development and modification of facility layouts, including production areas, utility systems, and supporting infrastructure. Collaborate with senior engineers to ensure compliance with industry standards, building codes, and regulatory requirements.
- Maintenance and Repairs: Support the maintenance and repair activities of facility equipment and systems, including HVAC, plumbing, electrical, and mechanical systems. Assist in troubleshooting issues, performing routine inspections, and implementing preventive maintenance plans. Identify and manage inventory of critical equipment spares.
- Energy Efficiency: Contribute to energy conservation efforts by identifying opportunities for efficiency improvements and participating in projects to optimize energy usage
- Compliance and Safety: Support compliance with regulatory requirements, such as FDA, ISO, and OSHA standards, by assisting in the implementation of safety programs, conducting risk assessments, and participating in quality /safety audits and inspections.
- Documentation and Reporting: Maintain accurate documentation of facility-related activities, including maintenance logs, work orders, equipment manuals, and safety records. Generate reports as needed and assist in maintaining the facility management system. Generate departmental related nonconformance & CAPA
- Project Support: Assist in the planning and execution of facility-related projects, such as expansions, renovations, or equipment installations. Contribute to project scope definition, validation, budgeting, and coordination with contractors and vendors.
- Cross-Functional Collaboration: Collaborate with other departments, including Manufacturing, Quality Assurance, and Regulatory Affairs, to ensure seamless integration of facility engineering activities with overall plant operations. Participate in cross-functional teams to address facility-related issues and support continuous improvement initiatives.
- Professional Development: Stay updated on industry best practices, new technologies, and regulatory changes related to facility engineering in the medical device manufacturing field. Seek opportunities for professional growth, such as attending training sessions or pursuing relevant certifications.
- Perform additional duties as required.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- Bachelor's degree Engineering (Mechanical Preferred) or an Associates in Engineering and 5+ years experience in the medical device/pharmaceutical industry.
- Knowledge of facility systems and infrastructure, including HVAC, plumbing, electrical, and fire protection systems.
- Familiarity with relevant industry standards and regulatory requirements, such as FDA, ISO, and OSHA.
- Strong analytical and problem-solving skills, with attention to detail and the ability to prioritize tasks.
- Good understanding of engineering principles and ability to apply them to facility-related projects and maintenance activities.
- Proficient in using engineering software tools, such as CAD, for facility design and modifications.
- Excellent communication and interpersonal skills, with the ability to work effectively within a team and across departments.
- Ability to adapt to a fast-paced manufacturing environment and handle multiple tasks concurrently.
- Strong commitment to safety, quality, and compliance.
- Previous internship or co-op experience in a facility engineering role is a plus.
- Experience with CMMS and CMS software
- Good writing and communication skills.
- Knowledge on personal computer and software like MS Word, Excel, Project and Power Point
- Self driven and able to work with minimal supervision
- Must be available in emergency situations, and / or work flexible hours.