It's an exciting time to join us!

 

General Description

Based at our GMP Manufacturing facility, this position will lead a cohesive team responsible for engineering support for all equipment, systems, and facilities supporting GxP Manufacturing and Lab operations.  The position will manage and direct capital project scope definition, estimating, execution, and p. He/she will apply existing and new knowledge of manufacturing equipment, systems, and facilities to enable technical success with stringent adherence to regulatory requirements, and Andelyn’s Quality System.

 

Schedule: Full-time (Benefits Eligible)  

 

Location:  Andelyn Corporate Center

 

                  1180 Arthur E Adams

 

                      Columbus, Ohio 43221

 

Principal Duties and Responsibilities

 

·       Manage 3 – 5 facility engineers

 

·       Assist in preparing engineering-related capital budgets. As required manage such projects, including timelines and budgets

 

·       Review projects, develop RFPs, conduct bidding, review quotes, and oversee installations. Establish work plans and staffing for each phase of the project and review status on an ongoing basis.

 

·       Manage and provide resources necessary to carry out duties and identify the occurrences of departures from the quality system, or from the procedures for performing engineering functions.

 

·       Assess contractor technical qualifications to meet project specification requirements.

 

·       Determine appropriate corporate procedures required for consistent and accurate engineering processes.

 

·       Consult with customers relative to their engineering support needs, especially on compliance issues and investigations.

 

·       Represent Andelyn in cGMP internal and external audits.

 

·       Provide “on-call” support on a rotating basis. Support regular 24-7 operation of the facility and respond to engineering issues as needed.

 

·       Support and own Change Controls, CAPAs, and Deviations in support of project activities.

 

·       Manage contract service providers; including scheduling, training on required SOPs, coordination, and ensuring all work and documentation is performed following cGMP requirements.

 

·       Exercise discretion, judgment, and personal responsibility.

 

·       Demonstrate a high level of integrity.

 

·       Maintain a positive attitude.

 

·       Attention to detail in all job functions.

 

·       Develop and define measurable objectives for the staff within their functional units to fit the objectives of the overall organization. Also is involved in organizational objectives on an executive level.

 

·       Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to ensure high productivity and contribution to the success of organizational goals.

 

·       Responsible for hiring, development, and related personnel processes.

 

·       Make use of essential people skills, including the ability to develop subordinates.

 

·       Ability to manage and influence people in the direct and lateral support structure.

 

·       Interprets Regulations for application within their functional unit.

 

·       Has business acumen and considers business impacts in planning and problem-solving.

 

·       Other duties as assigned.

 

Knowledge, skills, and abilities required 

 

·       Must possess a bachelor’s degree in engineering (Chemical Engineering, Mechanical Engineering, or Electrical Engineering)

 

·       Seven to ten years of experience in biologics or gene therapy manufacturing preferred OR extensive experience in a highly regulated field

 

·       Strong ability to troubleshoot and diagnose facility, utility, and process equipment issues

 

·       Experience in new construction and qualification/commissioning of a new facility or expansion

 

·       Strong project management and organizational skills

 

·       Cleanroom, packaging/filling & Isolator qualification, and operation experience preferred

 

·       Experience working in an FDA/EU regulated manufacturing facility

 

·       Excellent team facilitation, communication, and influencing skills

 

·       Excellent documented leadership skills and ability to navigate in a fast-paced environment

 

·       Demonstrated ability to assign priorities in a fast-paced and changing environment.

 

·       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.

 

 Minimum Physical Requirements

 

·       Frequently sitting/remaining in a seated position

 

·       Occasionally standing or walking

 

·       Occasionally independently lifting up to 50 pounds

 

·       Frequently talking on the phone or in-person

 

·       Frequently keyboarding

 

                                                                                     

 

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.  It is not to be construed as an exhaustive list of duties performed by the individual, 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.    

 

 

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.