Lead Validation Engineer

E Tech Group

$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • BS Engineering or Computer Science degree or equivalent
  • 5+ years of experience in engineering/control system documentation and change control
  • Familiarity with GAMP guidelines is a plus
  • Strong collaborative and teamwork skills

Responsibilities

  • Review and comprehend project scope and design
  • Develop and maintain project documentation, including design documents and test protocols
  • Collaborate with the project team to ensure validation requirements are met
  • Determine and document out-of-scope project items
  • Manage documentation schedules throughout project lifecycles
  • Engage with customers to understand their procedures and systems
  • Conduct Factory Acceptance Testing, Site Acceptance Testing, and qualification testing protocols

Benefits

  • 401k with company match and immediate vesting
  • Quick enrollment in Medical, Dental, and Vision coverage
  • Generous paid time off, including vacation and holidays
  • Emphasis on continuous learning and professional development opportunities
Full Job Description
We are seeking an enthusiastic and experienced a SeniorValidation Engineer (Life Sciences) to be responsible for leading or contributing to detailed hardware and software design of process automation control systems projects. This includes defining architecture requirements, developing detailed test protocols, software design specifications, functional design specifications, creating SAT/FAT documentation, and contributing to the overall control system design.

You will:
  • Review and understand scope, approach and design
  • Review documentation/validation requirements with the Project team
  • Develop required documentation (design documents and test protocols) for a Project.
  • Review documentation developed by peer engineers.
  • Maintain documentation through project life cycles.
  • Maintain schedule of documentation required for Projects
  • Identify and definition of out-of-scope items
  • Collaborate regularly with customers.
  • Maintain a comprehensive understanding of required customer procedures and policies
  • Possess a thorough understanding of customer equipment and systems
  • Participate in required meetings and training.
  • Assist with investigations.
  • Read and understand electrical drawings and design documents
  • Develop protocols and review completed reports for Factory Acceptance Testing, Site Acceptance Testing, and qualification testing.
  • Develop and maintain a quantitative approach for estimating documentation development hours
  • Independently manage project-related responsibilities
  • Be an ambassador who embodies our Core Values, prioritizing the success of E Tech Group, our clients, and the professional development of our associates.


You have:
  • BS Engineering or Computer Science degree or equivalent educational background
  • 5+ years of experience in engineering/control system documentation, and change control.
  • General understanding of GAMP is a plus
  • A DNA comprised of collaboration and teamwork.


Benefits & Perks:
  • 401k + match + prompt enrollment. E Tech Group employees are 100% vested upon entry.
  • Prompt enrollment into Medical, Dental, and Vision benefits.
  • Generous paid time off that includes paid vacation, paid holidays, paid family leave and sick time off.
  • Learning and growth are key parts of the E Tech culture. We provide you with training and continuing education from day one, so you can advance your career. As an E Tech associate, you can unlock your greatest potential through challenges and opportunities.


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