Manager, Computer System Validation Engineering

About AskBio

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.

Our principles:

  • Advance innovative science by pushing boundaries.
  • Bring transformative therapeutics to patients in need. 
  • Provide an environment for employees to reach their fullest potential. 

Our values:

  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  • Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

We have an opportunity for a Manager, Computer System Validation Engineering to join the AskBio team and be part of our continued success!

Position Overview 

The Manager, Computer System Validation Engineering, reporting to the Associate Director, Computer System Validation Engineering, will be responsible for managing the computer system validation process, maintaining validated state of all GxP systems, comply with GxP and Security policies, develop and maintain department procedures, and contribute to overall IT & CSV planning and management. The ideal candidate will have excellent organization, prioritization, and communication skills and be able to work effectively both independently and in a group/collaboratively. The Manager should also be an effective leader in alignment with AskBio Values. The Manager is expected to utilize good judgment and innovative ideas to achieve a solution within standard practices and procedures.

Responsibilities

  • Lead validation activities and work closely with business leaders, facilities engineering, and quality assurance to establish priorities and timelines for work.
  • Prepare, execute, and evaluate validation lifecycle documentation, as defined by the Validation Policy.
  • Establish and maintain validated state and maintain data integrity for validated computer systems.
  • Write and own standard operating procedures for the validation program and evaluate for continuous improvements.
  • Evaluate new products and services, including evaluation of vendor validation packages, and recommend actions based on findings.
  • Participate in regulatory inspections and customer audits, as necessary.
  • Remain current on regulatory guidances, trends, and regulations in both the EU and US.
  • Provide training to employees and contractors on Computer System Validation processes and data integrity concepts.

Required Education and Experience

  • Bachelor’s degree in Information Technology or related field. Work experience may substitute for education requirement.
  • 7+ years of validation experience in regulated, GxP environments. Related industry work will be considered.
  • Ability to multitask among multiple projects and teams and to work independently in a fast-paced, highly interactive environment.
  • Demonstrated ability to work with different personalities and styles efficiently and prioritize activities based on ambiguous or quickly changing information and environments is critical.

Preferred Experience and Skills

  • CSV experience with laboratory instruments, manufacturing equipment, and software applications.
  • 2 years of management experience.
  • Ability to manage timelines and deliverables among multiple parties, including vendors, clients, and internal stakeholders.
  • Detail oriented and committed to quality and compliance.
  • Excellent written and verbal communication skills.
  • Proficiency in Microsoft Office Suite (especially Excel and Access).

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or emailing us at talent@askbio.com.