Mechanical Process Engineer
2 weeks ago
Job Summary: The Mechanical Process Engineer will deliver mechanical technical support and hands-on maintenance for BIVI process and production operations, focusing primarily on filling, packaging, anaerobic, and bioreactor operations. The role involves providing technical troubleshooting and training for the setup and operation of production and utility equipment, covering all mechanical systems such as conveyors, cartoners, drives, fillers, turntables, bioreactors, tanks, agitators, pumps, compressors, and water systems, along with basic electrical troubleshooting and maintenance support for instruments, controls, robots, vision systems, and production handling equipment. Responsibilities will include troubleshooting, preventive maintenance, testing, repairing, modifying, and enhancing equipment reliability and performance. This position will also contribute to engineering activities related to design, estimating, proposing, and implementing projects involving electro-mechanical applications in the setup, testing, and acceptance of new equipment.
Work Schedule: 2nd Shift: Tue-Sat 3:00 PM - 11:30 PM
Key Responsibilities:
- Maintain production process equipment to support production schedules and quality standards, which may include additional operational equipment.
- Troubleshoot and implement corrective actions for equipment performance issues.
- Identify and seek approvals for equipment upgrades to enhance performance and reliability.
- Support the training of production and maintenance personnel regarding the operation and care of electro-mechanical equipment.
- Assist and support engineering projects involving electro-mechanical applications across all aspects of design, scope, performance parameters, testing, and implementation.
- Adhere to company policies and standard operating procedures (SOPs) related to all aspects of this role, including financial, environmental health and safety, and training.
- Pay particular attention to cGMP requirements for modifications to production equipment.
- Comply with regulatory requirements relevant to the EU, FDA, USDA, APHIS, OSHA, as well as local and state regulations.
- Perform additional duties as assigned by management to support operations.
- Provide supervisory relief and coverage as needed.
- Utilize CMMS per SOP to ensure proper documentation of work and compliance with preventive maintenance (PM) requirements and timelines, including the development of PM requirements.
- Stay updated on new technologies that impact personal knowledge and equipment.
Qualifications:
- Five (5) years of mechanical maintenance and basic electrical experience with equipment common to biological, pharmaceutical, or food processing.
- Experience in the installation, maintenance, and operation of a variety of manual and automated packaging and filling equipment.
- Familiarity with other aspects of bio-pharmaceutical production processes and equipment, including fermentation, bioreactors, autoclaves, pure steam, WFI, and associated biological production systems is advantageous.
- A college degree in an engineering-related discipline and/or technical institute training and certification in mechanical manufacturing applications is preferred.
- Desirable leadership or supervisory experience.
- PLC and controls expertise is a plus.
- Knowledge and experience in a cGMP environment is desirable.
- Familiarity with condition monitoring and predictive maintenance philosophy and technology is advantageous.
Eligibility Requirements:
- Must be legally authorized to work in the United States without restrictions.
- Must be willing to undergo a drug test and post-offer physical examination (if required).
- Must be 18 years of age or older.
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