Maintenance Planner

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

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.

They will assist the maintenance/metrology manager with scheduling preventative and corrective maintenance work orders with contracted service providers.

• Plan/Schedule Facility PM/Calibration/Repair Program
• Ensure that maintenance procedures are entered into BMRAM
• Report metrics on PM, calibration, and repair programs
• Directly coordinate shutdown activities and scheduling of PM/repair work
• Coordinate conversion of maintenance requests into work orders
• Perform breakdown statistical analyses and identify opportunities for improvement
• Reconcile maintenance schedules with Operations to ensure maximum efficiency of planned and unplanned shutdowns
• Responsible for developing and completing Deviation Reports, CAPAs and Change Controls as part of QMS in support of Site’s compliance readiness.
• Increase overall equipment availability through reduction of breakdowns
• Develop and manage spare parts stocking program
• Support breakdown repair activities and facilitate the supply of parts
• Facilitate completion of work order documentation
• Ensure that equipment files are maintained
• Serve as Administrator and subject matter expert of BMRAM
• Liaise with Operations to identify opportunities to complete backlog work orders
• Coordinate contractor planning to mesh with internal maintenance/shutdown activities
• Coordinate Site Service Providers
• Maintain contact with Service Provider scheduling functions
• Ensure that Service Providers are scheduled to perform tasks when the production schedule permits
• Support Facilities Projects
• Coordinate handover of new equipment from Engineering / Metrology team
• Work with engineering and maintenance/metrology team to ensure that PM programs are established
• Ability to clearly and concisely express thoughts in written procedures, protocols, and reports
• Ability to write maintenance procedures that clearly define required tasks
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Performs following established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Infrequent travel required
• Moderate involvement in audits
• Moderate involvement in customer relations
• Moderate responsibility for inspection outcomes
• Mentoring and professional development of staff
• Other duties as assigned

• A relevant four-year degree with 2 years of work experience with CMMS systems is preferred but work experience alone will also be considered. Background in the life sciences, biotechnology, or gene therapy industries preferred
• Experience with general facility systems and equipment such as Chillers, Boilers, Air Handlers, Compressors, etc is preferred.
• Experience with coordinating large scale shutdown/turnarounds
• Proven record of cost containment
• Knowledge of OSHA requirements
• Understanding of cGMP, GDP, and FDA requirements as they apply to maintenance.
• Experience with regulatory interaction/auditing
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
• 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 Paid Holidays plus 2 floating holidays annually.
• Company-paid 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.