Validation Engineer

Job Title: Validation Engineer

We are currently seeking a Validation Engineer to join the Forge Biologics team. In this newly created role, the Validation Engineer will work as part of a cross functional team executing quality validation project deliverables 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.

The Validation Engineer will take part in participating in execution, review, and release of commissioning and qualification of equipment, facilities, and utilities, as well as support other validation activities as needed. The individual chosen for this position will work in close partnership with all project leads and/or operational departments to support GMP manufacturing of drug products.

Responsibilities:

• Support execution of project and ongoing business validation deliverables (e.g., chamber mappings, autoclave qualification, tube welders and sealers, etc.)
• Ensure required policies and procedures are followed to support validation programs
• Provide development, review, and approval of validation documentation (URS/DQ/GAMP/IQ/OQ/PQ, etc.) for equipment, facilities, and utilities used in the manufacture and testing of GMP cell banks, drug substance, and sterile drug products. Examples of equipment includes Biological Safety Cabinets (BSCs), Bioreactors, Chromatography systems, Controlled Temperature Units (CTUs), and Analytical Instruments
• Ensure compliance to regulatory guidance on data integrity
• Support development, review, and continuous improvement of project related documents
• Provide validation support for investigations and assessment of system, product, and process impact
• Report validation and quality issues and trends to management
• Provide input to project timelines, scheduled activities, and status updates
• Maintain status of project deliverables

Requirements:

• Bachelor’s degree in Science, Engineering, or related discipline with 2+ years of experience within an FDA and EU 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 equipment, facilities, and utilities commissioning and qualification programs
• 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 experience working with high performance organizations and project teams
• Ability to work independently and collaboratively, as necessary, in a team environment
• 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 project activities.
• Detailed oriented
• Strong organization and communication skills

Special Knowledge or Skills Preferred:

• Knowledge of validation principles across multiple disciplines, which may include computerized systems, cleaning, aseptic process simulation, and/or process validation
• 2+ years’ related experience in a validation role within a pharmaceutical, biotech, or related industry with a preference toward direct Gene Therapy industry experience
• Mid-size company and/or start-up experience