Sr Engineer

hace 1 semana

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Position Overview:
We are seeking a Sr Engineer to independently direct and execute process optimization strategies and troubleshoot complex operational issues across manufacturing, pilot plant, and capital projects. This role requires the application of advanced engineering principles for system modifications, experiments, and capital project implementation. The ideal candidate will provide leadership in engineering practices, guide cross-functional teams, and deliver technical solutions for high-impact projects.

Key Responsibilities:

  • Lead complex engineering projects, often requiring innovative approaches and the development of new techniques and methods.
  • Develop and implement engineering policies and procedures that impact multiple teams and departments.
  • Supervise and coordinate the work of a team of engineers and technicians, providing guidance on technical issues and best practices.
  • Serve as a subject matter expert in a specialized area of engineering, overseeing advanced techniques and methodologies in project execution.
  • Develop technical solutions for complex, high-impact issues using creativity and advanced problem-solving skills.
  • Partner with cross-functional teams, including research, process development, quality assurance, and validation, to define and recommend design and system improvements.
  • Collaborate with project managers to ensure timely, within-budget completion of engineering projects, coordinating with consultants and contractors as needed.
  • Lead or contribute to the execution of validation protocols and ensure adherence to GLP/GMP standards.
  • Develop and oversee validation procedures for new equipment installations and modifications.
  • Ensure all processes and protocols comply with regulatory standards, supporting inspections as required.
  • Coordinate the development of project budgets and schedules, including multi-disciplinary project scopes.
  • Manage contractor and vendor relationships, ensuring quality and timely delivery of services.
  • Facilitate effective project completion and follow-up, ensuring all goals and requirements are met.

Skills and Competencies:

  • Proficiency in problem-solving, applied engineering, and technical report writing.
  • Deep knowledge of GMP/GLP standards and validation protocol requirements.
  • Ability to manage multiple projects, coordinate with diverse teams, and adapt to various communication styles.
  • Skills in budget management, project scheduling, contractor/vendor management, and project facilitation.
  • Expertise in areas such as validation protocol writing, technical presentations, and analytical problem-solving.
  • Experience in financial analysis tools, and demonstrated leadership in negotiation, team-building, and conflict resolution.

Requirements

Qualifications:

  • Education:
    • Doctorate degree, or
    • Master’s degree with 3 years of experience, or
    • Bachelor’s degree in Engineering with 5 years of experience.
  • Preferred Skills and Experience:
    • Working knowledge of pharmaceutical/biotech processes, validation processes, and regulated documentation.
    • Background in parenteral products, vision systems, device assembly, and packaging.

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