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Sr. Validation Engineer

LifeSprout
Baltimore, MD
  • Posted: over a month ago
  • Full-Time
Job Description

Position: Senior Validation Engineer

Position Overview:

The Senior Validation Engineer will be responsible for developing the overall company strategy as it relates to qualification and validation and for managing the activities directly associated with the program. This position will act as the subject matter expert for development of validation strategies for new processes, changes to existing designs, and design transfer activities for new product development.

Responsibilities:

  • Refine company philosophy with regards to all aspects of validation and author/revise associated documents (Validation Master Plan, SOPs, etc.) to align with approach.
  • Develop testing strategies by identifying critical equipment, process parameters, and quality attributes and performing risk analyses.
  • Define and create sampling plans based on sound statistical concepts and assist in the development of acceptance criteria.
  • Author/review protocols and reports for qualification/validation activities related to equipment, software, and processes and provide support for execution of those studies.
  • Troubleshoot and investigate failures and assist in problem-solving and long-term changes as part of process improvement.
  • Facilitate collection and trending of critical quality attributes and process control data.
  • Participate in the development of process characterization and controls for new products to ensure consistency with validation strategy.
  • Provide support during internal audits and regulatory inspections.

Qualifications:

  • Undergraduate degree in life sciences, engineering, or scientific discipline with 10 years of validation experience in industry.
  • A minimum of 5 years directing activities and managing an overall validation program.
  • Solid understanding of the chemical mechanisms associated with biomaterials.
  • Strong knowledge of statistical analysis and process controls.
  • Demonstrated proficiency with quality system procedures and medical device directives, 21 CFR 820, ISO 13485, ISO 14971, and related international standards.
  • Demonstrated ability to execute on deliverables and manage milestones.

Preferred:

  • Graduate degree in relevant field or 5 years of experience.
  • Previous experience with analytical assay optimization and validation.

Eligibility to work in the U.S. is required.

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Company Background:

Founded in September 2015 as a spinout from Johns Hopkins University, LifeSprout is a medical device company developing the next-generation of soft tissue alternatives for aesthetic and reconstructive medicine. The company is led by a management team well-versed in the business, clinical, and scientific aspects of medical device company operation. LifeSprout’s first product; an injectable filler for soft tissue reconstruction, will be regulated as a Class III medical device under the PMA pathway; this will be followed by several products in earlier stages of development.

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LifeSprout

Address

Baltimore, MD
USA

Industry

Manufacturing

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