Facilities Engineer II Plasmids

It’s an exciting time to join us!

The Andelyn Biosciences engineering group is seeking a motivated individual to join our growing team as an experienced Facility Engineer II for Plasmids.

Andelyn Biosciences is an industry-leading cGMP Contract Development and Manufacturing Organization dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in translational and regulatory science to develop safe and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope in the minds of every patient and family.

The Facility Engineer II in Plasmids will provide hands-on engineering and maintenance technical support for planning and implementing infrastructure support of facilities/buildings, utility, lab, and manufacturing equipment. Working as part of multi-disciplinary engineering, automation, maintenance, and metrology team, the Facility Engineer will ensure installation, preventative maintenance, operational support analysis, repair, and or troubleshooting activity is properly supported in compliance with engineering specifications, and current Good Manufacturing Practices guidelines. This position requires the ability to communicate effectively throughout all levels of the organization, facilitate technical projects, provide support for equipment, environment, and facility infrastructure. The ideal candidate should have experience with electrical distribution including generation, HVAC, Building Automation systems, boiler systems, and precision lab equipment, including effective troubleshooting abilities. Familiarity with Computerized Maintenance Management Systems (CMMS) is a plus. 

Schedule:  Fulltime (Benefits Eligible)

Locations: 

Manufacturing site                      Andelyn Development Center

1180 Arthur E Adams Drive        5185 Blazer Parkway

Columbus, OH 43221                 Dublin, OH 43017

Principal Duties and Responsibilities

• The Facility Engineer II provides hands-on technical support for facility/ building processes, utility, lab, and manufacturing equipment in Plasmids.
• Working as part of a focused multi-facility team, the Facility Engineer will ensure any modification, installation, preventative maintenance, operational support, or troubleshooting activity is properly completed in compliance with engineering specifications and current Good Manufacturing Practice guidelines.
• This position requires the ability to lead projects, direct support personnel, facilitate meetings, and provide consistently, and professional communication throughout all levels of the organization.
• Prepare, maintain, and follow procedures for the maintenance activities, and associated processes to adhere to FDA regulations, company, local and state requirements.
• Monitor instrument maintenance results and implement corrective actions for out of specification conditions
• Effectively prioritize projects, workload, and emergency requirements as needed
• Coordinate equipment and instrument PM/Repair activities and serve as a customer point of contact
• Ensure that equipment files are maintained per Good Engineering practices
• Provide technical maintenance support to all operational, maintenance, and calibration departments throughout daily   processes
• Develop, review, revise, and maintain SOPs for Engineering and Maintenance processes as assigned
• Assist with EHS activities when applicable and appropriate
• Remain current on industry and FDA engineering standards and trends
• Coordinate contracted service providers and ensure that work performed meets regulatory expectations
• Manage contracts to ensure appropriate service levels at acceptable cost levels
• Establish agreements, as requested, to assure coverage of critical systems
• Coordinate handover of equipment from Engineering to Maintenance
• Position has responsibilities at multiple locations in central Ohio (Columbus and Dublin)
• Ability to clearly and concisely express thoughts in written procedures, protocols, and reports
• Comfortable working in a production environment with multiple priorities
• Comfortable establishing culture of performance
• Readily adapts to changing job duties
• Establishes a culture that emphasizes responsiveness     

Knowledge, Skills, and Abilities Required

• Bachelor’s Degree in Mechanical, Chemical, or Electrical Engineering required.
• Minimum of 5 years of experience supporting Pharmaceutical Manufacturing or Laboratory operations
• Experience with Plasmids preferred.
• Ability to coordinate and lead daily team activities. 
• Experience with operation and maintenance of HVAC systems such as air handlers, chillers, heat exchangers
• Ability to understand mechanical layouts and electrical/pneumatic schematics (P&IDs)
• Job assignments can be complex in nature, requiring intrinsic planning, project leadership, technical skills, and communication to be successful in meeting objectives
• Experience with process systems and equipment such as filters, pumps, tanks, mixers, autoclaves, fillers, clean rooms labeling and packing equipment, etc. preferred.
• Working knowledge of Plant Utility systems and equipment such as pumps, compressors, chillers, boilers, etc.
• Knowledge of OSHA requirements and understanding of cGMP requirements as they apply to manufacturing
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting. CAD experience is a plus
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment
• Must possess a client-focused mindset in daily tasks

Minimum Physical Requirements

• Occasionally Sitting
• Frequently Walking/Standing/Stooping
• Independently lifting up to 50 pounds
• Occasionally Talking on the phone or in-person
• Frequently Typing on a computer keyboard
• May require the ability to aseptically gown or wear other PPE on a regular basis

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned.  It is not to be construed as an exhaustive list of duties performed by the individual notified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.    

EOE M/F/Disability/Vet

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.