Validation Engineer II

Job Locations US-MA-Bedford
Posted Date 2 months ago(4/23/2020 11:29 AM)
Job ID
2020-1315
# of Openings
1
Category
Development

Overview

The Validation Engineer-II shall support the validation activities associated with equipment, utility, facility and computerized system at Ocular including commissioning, and qualification (IQ, OQ and PQ).  The validation engineer will also ensure the maintenance of the validated state, of all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug substance platforms. The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks. 

The validation engineer will also be responsible for generating risk assessments, authoring technical reports, assisting with factory and site acceptance testing of equipment or developing new procedures/methods.

 

Responsibilities

  • Provide technical input to strategy/philosophy for validation activities
  • Support the execution of routine validation activities and validation assignments involving the qualification of new and existing facilities, utilities, equipment and/or computerized systems.
  • Write, execute, and lead facilities and equipment validations, reviewing and analyzing data, adhering to GMP regulations. Support cross-functional teams to establish site validation master plans, cleaning validation master plans, etc. for complex product development projects.
  • Represent process validation during tech transfer activities as required.
  • Support and interface with global PPQ community of practice where needed to ensure alignment and consistency with global practices.
  • Support validation activities related to drug delivery product/device development, and in-house commercial manufacturing.
  • Demonstrate a strong understanding of engineering fundamentals.
  • Coordinate calibration activities.
  • Communicate project plans, status updates and progress against milestones to project team members.
  • Generate technical documents including test protocols and reports documenting product and process knowledge.
  • Collaborate effectively with development group and project team members
  • Incorporating continuous process improvements and policies including functional and user requirement specifications.
  • Technical support for manufacturing for equipment or facility validations, participating in regulatory inspections.
  • Knowledgeable about good documentation practices.
  • Perform other validation engineering duties as assigned.

Qualifications

  • Minimum of bachelor’s degree in Chemistry, Biology, Pharmaceutics, Biomedical, Chemical Engineering or related discipline. Advanced degree (MS/PhD) desirable with 2+ years of industry experience in pharmaceutical or medical device development.
  • Ability to work with people at all levels.
  • Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) for clinical batch manufacturing of drug/drug-device products.
  • Demonstrated written and verbal communication skills.
  • Demonstrated data analysis skills.
  • Effective problem-solving skills and proficient with Microsoft Office, particularly Word and Excel.
  • High degree of initiative and self-motivation.
  • Ability to manage and meaningfully advance diverse tasks and projects.
  • Experience creating technical, written content.
  • A hard-working, team-player that is passionate about science and can effectively. collaborate in a dynamic, cross-functional matrix environment.
  • Strong understanding of mechanical engineering principles and methodologies are preferred.
  • Experience in lyophilization, extrusion techniques and injection molding preferred.
  • Working Condidtions:
    • Production Floor - gowning requirements
    • R&D Laboratory
    • Bending, Lifting

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