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Solid Biosciences

Senior Validation Engineer

551 - Operations – Cambridge, Massachusetts
Department 551 - Operations
Employment Type Full-Time
Minimum Experience Experienced

Summary:

You will be responsible for validation activities related to the following areas: DQ, IQ, OQ, PQ, requalification/validation life-cycle, cleaning, sterilization, and computer systems. Provides C&Q support to projects/programs. Provides Engineering support for process and utility systems, maintaining these systems in a validated state of control, ensuring uninterrupted business continuity.

Key Duties & Accountabilities:

  • Lead the C&Q project team from the design and build phase of projects to the completion of validation activities, deliver projects which meet GMP requirements and regulatory agency expectations
  • Direct activities associated with process equipment and GMP utility commissioning, qualification, and validation
  • Evaluate and manage facility, utility, equipment, and computerized system change controls, ensuring compliance with the Solid Biosciences QMS
  • Write policies and procedural SOPs as needed to define Solid Biosciences’ validation program
  • Technical lead for project protocols, execution, and reporting to ensure the appropriate level of detail and compliance is maintained throughout the C&Q lifecycle
  • Manage contract resources and contracts under the responsibility of C&Q
  • Work with Capital Project Management to generate and issue periodic progress and cost reports
  • Performs other related duties and ad hoc projects as required by position

Core Competencies Required:

  • Organization
  • Communication
  • Problem Solving/Critical Thinking
  • Judgement and Decision-making

Knowledge: Education, Experience, & Skills:

  • Bachelor of Science Degree in a Life Sciences or Engineering discipline
  • 10+ years Validation experience required
  • Minimum of 10 years’ experience in either of 1) engineering 2) validation or 3) automation in a life sciences environment
  • Knowledge of regulatory requirements as relates to C&Q for a pharmaceutical facility
  • Experience leading a team of internal and external engineering resources
  • Capital project experience, project management experience preferred with a focus on C&Q
  • Automation validation experience a plus
  • Gene therapy facility experience a plus
  • Excellent communication skills and ability to build key networks and business relationships across all levels of the business 

Travel Commitment:

  • Some travel may be required
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  • Location
    Cambridge, Massachusetts
  • Department
    551 - Operations
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced
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