Senior Validation Engineer
Bluebird Bio, Durham, North Carolina, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced Senior Validation Engineer to support the implementation and execution of bluebird’s validation program for our internal vector manufacturing facility. This includes initial validation and qualification of equipment, utilities, facilities and CSV along with implementation of the CPV program. The candidate will assess validation packages, perform gap analysis to User Requirements and develop plans and protocols that comply with company policies and procedures. In addition, the individual will collaborate with Quality Assurance, IT, Manufacturing, and other cross-functional teams as required.
About the Role:
- Write, execute, summarize, provide technical input and lead validation activities for: Analytical instruments, Computer Systems (applicable to complex instruments and manufacturing equipment), Equipment, Utilities, and Facilities
- Development of Validation Plans and Validation Plan Summary Reports
- Develop and provide guidance on internal validation documents including
- Provide technical input to protocol exceptions to efficiently drive resolution
- Develop and assess CAPAs, Change Controls, Deviations, Investigations and Risk Management as they pertain to validation
- Provide technical input to strategy/philosophy for validation activities
- Represent validation during tech transfer activities
- Front facing during agency inspections representing the validation function and support audit responses for observations impacting validation.
- Lead and manage complex validation and technical projects
- Author and review sections of regulatory filings and annual product quality reviews.
- Minimum of Bachelor’s degree in science, engineering or related discipline
- Eight (8) years of experience in the execution of validation studies in a regulated manufacturing environment
- Thorough knowledge and understanding of FDA and international health authority expectations
- Ability to effectively participate in a dynamic work environment consisting of clinical and commercial manufacturing
- Subject Matter Expertise in authoring and review/approval of SOPs
- Superb organizational and communication skills and “do-what-it-takes” attitude
- A passion for addressing the critical unmet medical needs of patients
- Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
- Provide mentoring to junior team members to support development of overall group.
- Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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