Facilities Engineer II

Overview of Andelyn Biosciences

The Andelyn Corporate Center (ACC) is dedicated for cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

Our Values are founded in our origin story.

Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

What you will do.

The Facility Engineer II 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.

Familiarity with Computerized Maintenance Management Systems (CMMS) is a plus.

• The Facility Engineer provides hands-on technical support for facility/ building processes, utility, lab, and manufacturing equipment
• Working as part of a focused multi-facility team, the Facility Engineer II 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 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
• Develop, conduct, and record test methods for facilities/utilities/HVAC/instrument systems troubleshooting
• 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 and ensure that work performed meets regulatory expectations
• 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
• Manage contracts to ensure appropriate service levels at acceptable cost levels
• 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
• Readily adapts to changing job duties
• Supports culture that emphasizes responsiveness
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Attention to detail in all job functions
• Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Anticipating problems and removing obstacles to enable staff to perform tasks as assigned
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
• Developing and enforcing procedures and controls
• Has budgetary responsibility
• Exercise crucial people skills
• Ability to manage and influence people in the direct and lateral support structure
• Drives timelines and development through the broad influence
• Other duties as assigned

• Bachelor’s Degree in Chemical, Mechanical, or Electrical Engineering required.
• Minimum of 3 years of experience supporting Pharmaceutical Manufacturing or Laboratory operations
• 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 schematic drawings (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 bioprocess systems and equipment such as filters, pumps, tanks, mixers, autoclaves, fillers, clean rooms, labeling and packing equipment a plus.
• 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 the manufacture of pharmaceuticals
• 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). CAD experience is a plus
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment
• Must possess a client-focused mindset in daily tasks
• Must possess prior experience handling confidential information and the ability to maintain confidentiality

• The pride of contributing to the development and manufacturing of life-saving therapies
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to work alongside experts that have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible day one for medical, dental and vision insurance plans with basic vision at 100% company-paid
• 160 hours of Paid Time Off annually
• 11 Company Paid Holidays plus 2 floating holidays annually.
• Company Paid Life Insurance
• 401(k) Match
• Company Paid short and long-term disability.
• 4 weeks of Paid Parental Leave for birth and adoption
• Adoption Assistance
• Tuition Reimbursement and Student Loan Repayment Assistance
• Company Paid LinkedIn Learning access.
• Employee Assistance Programs
• Flexible work options (role specific)

As an organization, we are committed to creating an environment where everyone ACCTS.