Sr. Engineer

Essential Functions 

1. Work closely with Manufacturing Engineering to evaluate, recommend, and implement new or improved manufacturing processes to ensure product manufacturability, strengthen manufacturing’s operational capabilities, optimize processing methods, ensure process reproducibility, improve batch yields, and reduce process cycle times.

1. Coordinate and assist in the efforts towards the specification, procurement, fabrication, qualification, and validation activities for new or modified equipment.

1. Support Engineering, Manufacturing, and Facilities by developing drawings for new or revised components, equipment, processes, or infrastructure.

1. Manage and function as the system administrator for the electronic Preventative Maintenance Program within the IQMS Software for all equipment assets.  Develop and maintain the required preventative maintenance schedules for all equipment assets procured or designed/built in house.  Responsible for issuing all new PM workorders and reviewing completed workorders.  Responsible for maintaining permanent records of PM activities for all Assets.

1. Play a major role in the investigation, review, and remediation of system and/or equipment failures by contributing relevant equipment experience, along with expertise in electrical, mechanical, pneumatic, and PLC systems.

1. Develop and perform the Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) documentation and drawings required for compliance with current Good Manufacturing Practices (cGMP) and International Standards Organization (ISO).  Follow regulatory requirements for making changes to validated equipment, packaging, and processes.

1. Adhere to the company’s documentation system of Standard Operating Procedures (SOP’s), cGMPs, and ISO requirements. This includes producing and maintaining drawings so that we may operate effectively and adhere to regulatory requirements.

1. Ensures all work is in compliance with all Current Good Manufacturing Practices (cGMP) and International Organization for Standardization (ISO) requirements.

1. Manage the effort to create, maintain, and execute agreed upon timelines and budgets for projects involving new, or updates to, equipment or manufacturing processes.

1. Support manufacturing start-up, operation, and shut down as needed to support Sr. Manufacturing Manager and Manufacturing Engineering.

1. Assist Manufacturing Engineering to train employees in the operation of new equipment. Train Manufacturing Engineering to maintain the new equipment.

Other Duties and Responsibilities 

• Maintain an “Engineer for Safety” and “Risk Analysis” mentality for all products, component and equipment designs and process implementations.
• Investigate customer complaints and Corrective and Preventative Action (CAPA) reports with Quality Assurance Department.
• Document failure analysis and write final reports as required.
• Assist departments with the setup of training programs to satisfy OSHA, Fire Safety, Hazardous Material handling, and other governmental regulations that affect facility operations.
• Maintain compliance with the regulations of the Occupational Safety and Health Administration (OSHA), Fire Safety, Hazardous Materials, safety training, etc.
• Participate in proactive team efforts to achieve departmental and company goals.
• Comply with all company policies, practices, and procedures.
• Assist with internal and external audits as needed.
• Comply with all applicable regulations.