Sr. Validation Engineer II, Gene Therapy

Job Description

About This Role

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Sr Validation Engineer II, Gene Therapy is responsible for leading andcoordinating all equipment, cleaning, utility, and facility validation efforts at theGene Therapy Manufacturing Facility. Initially this role will support the greenfield project and will transition to a site validationrole. Itprovides on the floor execution support, tracking, and updates by performing duties personally or through contractors or dotted line reports. You will lead multi-function teams to implement change and improve on existing processes, and leadproject initiatives related to global alignment of validation practices, site validation innovation, improvements, and/or execution. You also representthe validation department / function / company during internal /external audits and regulatory inspections.

What You’ll Do
  • Specifically design & develop validation protocols, provide expertise to associated equipment & automation design / modifications, and support equipment startup & commissioning efforts as required
  • Maintain personal training, goal development / completion, compliance workflow tracking, and progress tracking
  • Lead validation innovation project efforts requiring cross-functional & contract resources, and complete project management tracking of deliverables for metrics & reporting
  • Lead validation efforts for new and modified systems
  • Represent validation systems and data packages in regulatory audits

Who You Are

You have an ability to recognize deviation from accepted practice, and judgment in resolving problems & making routine recommendations. You can manage small to medium engineering projects with little direction, as well as work with and provide direction to contractors.

Qualifications

Education
  • Bachelor’s Degree with a minimum of 8 years’ experience OR MBA/MS with a minimum of 6 years in pharmaceutical or biotech manufacturing environment

Required Skills
  • Experience authoring and executing validation protocols for equipment, cleaning, and facility qualification
  • Experienced with documentation requirements for GMP manufacturing facilities including change control and validation systems
  • Practical knowledge and application of GMP and FDA/EMA regulations, and audit support
  • Excellent verbal and written communication skills, demonstrated technical proficiency and creativity, and excellent organizational and time management skills
  • Competency in MS Word, MS Excel, MS Power Point and MS Project
  • Must be able to prioritize multiple commitments and technical problems
  • Must have the ability to shift priorities according to changes in department / facility needs and be open to different ideas / approaches
  • Must be willing to work in an open office environment

Preferred Skills
  • Validation experiencesupporting gene therapy manufacturing equipment and clean utility / facility equipment (air handlers, water systems, clean steam systems, and clean gas systems)
  • Competency in Kneat validation document system




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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