Skip to main content

This job has expired

You will need to login before you can apply for a job.

Validation Manager

Employer
Forge Biologics
Location
Columbus, Ohio
Start date
Nov 26, 2022

View more

Discipline
Engineering, Validation Engineer
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest

Company Overview:

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company.  Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality.  Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters.  The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.  By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. 

Position Overview:

We are currently seeking a Validation Manager to join the Forge Biologics team. In this newly created role, the Validation Manager will work as part of a cross functional team leading quality validation programs to ensure that products and processes for both internal and external gene therapy programs meet the appropriate regulatory agency requirements, internal company standards, and current industry best practices.

Working in a matrix management environment that includes Development, Manufacturing, Operations, IT, Project Management, Quality, and Supply Chain, the candidate will be responsible for maintaining a detailed understanding of the status of each validation program to prioritize and effectively execute on validation related activities.

The Validation Manager will take part in participating in site projects as well as the continued support of the facility moving forward. The individual chosen for this position will work in close partnership with all validation project leads and project team members to support GMP manufacturing of clinical and commercial products. This includes but may not be limited to commissioning, qualification, and/or validation of GMP Systems and Processes.

Responsibilities:

  • Provide program management for Commissioning & Qualification (C&Q) of Manufacturing and Laboratory systems and areas, Aseptic Process Simulation (APS), Periodic Review & Requalification, and Sterilization programs
  • Provide review and approval of project deliverables (impact assessments, requirements specifications, design qualifications, protocols, reports, etc.), ensuring required policies and procedures are followed to support validation programs
  • Ensure compliance to regulatory guidance on Data Integrity
  • Support development, review, and continuous improvement of site SOPs and project related documents.
  • Report validation and quality issues and trends to Senior Management
  • Perform verification testing and document generation as necessary.

Requirements:

  • Bachelor’s degree in Science or Engineering or related discipline with 8+ years of experience, with a minimum of 6+ years validation experience within an FDA regulated pharmaceutical, biotech, or related industry/manufacturing company
  • Physical Demand: Ability to walk 1-3 miles, stand for 3-6 hours, and lift 10 – 40 lbs. during a workday, as required.
  • Travel requirements: 0 to 15%
  • In our commitment to the safety of our employees and customers, a COVID vaccination is required for employment

Special Knowledge or Skills Required:

  • Working knowledge of manufacturing and laboratory systems (equipment, facilities, and utilities commissioning and qualification programs
  • Working knowledge of pharmaceutical manufacturing processes
  • Experience in the application of pre-clinical, clinical, and commercial cGMPs
  • Experience with aseptic processing and clean room standards
  • Ability to communicate with respect to technical or project management issues, both verbally and in written form
  • Demonstrated leadership ability and experience working with high performance organizations and project teams
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Ability to work hours necessary to support production and/or product transfer activities.
  • Detailed oriented
  • Strong organization and communication skills

Special Knowledge or Skills Preferred:

  • Knowledge of validation principles across multiple disciplines, which may include Commissioning and Qualification (C&Q), Computer System Validation (CSV), cleaning validation, Sterilization (Autoclave Steam Sterilization), Filter Validation, Shipping Validation, Aseptic Process Simulation (APS), and/or Process Validation (PV/PPQ/CPV)
  • 8+ years’ related experience within a pharmaceutical, biotech, or related industry with a preference toward direct Gene Therapy industry experience
  • Small/mid-size company and/or start-up experience
  • Experience in interactions with domestic and international regulatory agencies.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert